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FIRST AFRICAN
MEDICINES REGULATORY
AUTHORITIES CONFERENCE
FINAL REPORT
First African Medicines Regulatory Authorities Conference
Final Report
WHO/AFRO/EDM/09.1
In collaboration withDepartment of Medicines Policy and Standards (PSM)
Department of Technical Cooperation for EssentialMedicines and Traditional Medicine (TCM)
Addis Ababa, Ethiopia31 October – 3 November 2005
AFRO Library Cataloguing-in-Publication Data
First African Medicines Regulatory Authorities Conference: Final Report
1. Legislation, Drug2. Drug Industry 3. Economics, Pharmaceutical4. Public Health5. Congresses as Topic6. Africa
ISBN : 978 929 023 1417 (NLM Classification: QV 33 )
© WHO Regional Office for Africa, 2009
Publications of the World Health Organization enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal Copyright Convention. All rights reserved. Copies of this publication may be obtained from the Publication and Language Services Unit, WHO Regional Office for Africa, P.O. Box 6, Brazzaville, Republic of Congo (Tel: +47 241 39100; Fax: +47 241 39507; E-mail: [email protected]). Requests for permission to reproduce or translate this publication – whether for sale or for non-commercial distribution – should be sent to the same address.
The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.
The mention of specific companies or of certain manufacturers' products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either express or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization or its Regional Office for Africa be liable for damages arising from its use.
Printed in India
ABBREVIATIONS ................................................................................................................I
EXECUTIVE SUMMARY .......................................................................................................III
1. INTRODUCTION...........................................................................................................11.1 Background...........................................................................................................11.2 Participants ...........................................................................................................2
2. OPENING OF THE MEETING ........................................................................................22.1 Introduction to the conference .............................................................................22.2 Welcome address .................................................................................................42.3 Official Opening of the Conference ......................................................................42.4 Message from WHO/HQ .......................................................................................52.5 Administrative arrangements ................................................................................5
3. METHOD OF WORK .....................................................................................................6
4. MAIN TOPICS PRESENTED AND DISCUSSED AT PLENARY .........................................64.1 Medicines regulation in sub-Saharan Africa: an overview .......................................64.2 Country initiatives to promote effective medicines regulation .................................84.3 Medicines regulation development path: concept for discussion .........................134.4 Revamping medicines regulation to respond to public health priorities ...............144.5 Medicines regulation harmonization in Africa ......................................................154.6 Effective law enforcement and regulation of distribution .....................................224.7 Ethical practice, conflict of interest, code of conduct in medicines regulation .......224.8 Rapid alert system on quality of medicines .........................................................234.9 Counterfeit medicines: framework convention ...................................................234.10 Current topics ....................................................................................................24
5. DEVELOPMENT OF THE REGIONAL STRATEGIC PLAN ..............................................28
6. RECOMMENDATIONS ................................................................................................33
7. CLOSING CEREMONY .................................................................................................34
ANNEX: LIST OF PARTICIPANTS ........................................................................................35
CONTENTS
Page
ABBREVIATIONS
ADR Adverse Drug Reaction
AFDRAN African Drug Regulatory Authority Network
AIDS Acquired Immunodeficiency Syndrome
AMRAC African Medicines Regulatory Authorities Conference
ARFI Adverse Reactions Following Immunization
ARV Antiretroviral Medicines
AU African Union
CEAC Economic Community of Central Africa States
COMESA Common Market of Eastern and Southern Africa
DACA Drug Administration and Control Authority
DFID Department for International Development (of United Kingdom)
DRA Drug Regulatory Agency/Authority
DPM Directorate of Pharmaceutical Services
EAC East African Community
EU European Union
ECOWAS Economic Community of West African States
EDM Essential Drugs and Medicines Policy
EML Essential Medicines List
GCP Good Clinical Practices
GDP Good Distribution Practices
GMP Good Manufacturing Practices
GTN Global Training Network
ICDRA International Conference of Drug Regulatory Authorities
ICH International Conference on Harmonization of TechnicalRequirements for the Registration of Pharmaceuticals for Human Use
IEC Information, Education and Communication
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HIV Human Immunodeficiency Virus
MDG Millennium Development Goal
MOH Ministry of Health
MRA Medicines Regulatory Authority
NDA National Drug Authority
NDP National Drug Policy
NEPAD New Partnership for Africa's Development
NMRA National Medicines Regulatory Authority
NPO National Professional Officer
PMS Post Marketing Surveillance
PSM Medicines Policy and Standards (Department of WHO)
QC Quality Control (of Medicines)
QSM Quality and Safety of Medicines (Team of WHO/PSM)
RAS Rapid Alert System
RDU Rational Drug Use
SADC Southern African Development Community
TCM Technical Cooperation on Essential Drugs and Traditional Medicines (Department of WHO)
TRIPS Trade-Related Aspects of Intellectual Property Rights
UEMOA West African Monetary and Economic Union
WAHO West African Health Organisation
WCO WHO Country Office
WHO World Health Organization
WR WHO Country Representative
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EXECUTIVE SUMMARY
Currently, about 7% of the 46 sub-Saharan African countries have a moderately developed medicine regulatory capacity. Of the remaining, about 63% have minimal capacities whereas 30% do not have a National Medicines Regulatory Authority (NMRA) in place.
Over the years, the World Health Organization together with other international organizations and donor countries has been supporting African countries to establish and strengthen their medicine regulatory authorities. Despite the efforts made however situations have not changed much. Some of the reasons for this have been absence of government support, lack of adequate number of trained and qualified staff, high staff turn-over due to low salaries and lack of incentives, inadequate and unsustainable funding of the NMRAs, weak infrastructure.
A conference of African Medicine Regulators held from 30 October–3 November 2005 in Addis Ababa, Ethiopia discussed the medicine regulatory situation in the subregion and came up with the following as the main characteristics: ineffective licensing system, weak product registration, poor inspection practices, inadequate access to quality control laboratories, inadequate market control, non existence of pharmacovigilance and control of promotion, lack of clinical trials, oversight, inadequate communication and information exchange system, lack of transparency and accountability and conflict of interest.
The result is in many of sub-Saharan African countries medicines are imported into the countries or manufactured locally without any appropriate quality assurance safeguards. In addition, in many of these countries medicines are smuggled across borders and sold in open market places and on streets, leading to a high prevalence of sub-standard and counterfeit medicines. Reports indicate that in sub-Saharan Africa, on the average, as much as 30% of samples of medicines tested fail quality tests.
The meeting also identified inadequate government and public support; law status given to NMRA; inadequate number of qualified and skilled staff; lack
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of legislation, regulations, guidelines and procedures; inadequate and unsustainable resources; weak enforcement mechanisms and sanctions and corruption to be the main barriers to the improvement of medicine regulation in the subregion.
The Conference recommended the following strategies to improve medicine regulation in the sub-region:
Take gradual, feasible and realistic steps towards regulationReview and strengthen legislationPut in place an appropriate structure to support effective regulationReview and develop/strengthen regulations, guidelines and procedures to support regulationEstablish mechanisms to ensure financial sustainability of MRAsSet up mechanisms to ensure recruitment, training and maintenance of adequate human resources Put in place advocacy strategies for effective drug regulationImprove IEC for the sensitization of stakeholders, civil societies and the general public to appreciate and support effective drug regulationSet up systems for managing and sharing of informationPut in place mechanisms for monitoring and evaluation of implementation of drug regulation
In conclusion, the Conference developed a five year plan for the development of medicine regulation in the sub-region and recommended that:
Develop and implement strategies to promote effective medicinesregulation. Prepare and submit to WHO/AFRO a 2-year national plan indicating thepriority activities to be undertaken in 2006–2007 to improve medicines regulation.Explore regional collaboration and support the creation of networks to share information on medicines regulation.
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National Medicine Regulatory authorities should:
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Government should:
WHO/AFRO should:
Support medicines regulation and provide adequate funds to NMRAs to perform their functions. Advocate for and support sub-regional and regional harmonization initiatives.Support human resources development for medicines regulation.Institutionalize the development and strengthening of autonomous NMRAs.
Organize a conference for all African Medicines Regulatory Authorities at least once every two years to further the exchange of information and experiences of medicines regulation in the region.Ensure better coordination of medicines regulatory activities in the region. Advocate for countries to establish MRAs and adequately fund medicinesregulation. Strengthen and expand MRA assessments to other countries in the region.Support capacity building and training of MRA staff. Ensure that all existing tools and documents are available in both English andFrench. Promote the exchange and use of technical expertise available in the region.
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1.1 BackgroundCurrently it is estimated that about 30% of the 46 sub-Saharan African countries do not have a National Medicines Regulatory Authority (NMRA) in place. About 7% of the remaining countries have a moderately developed capacity, and that a massive 63% have minimal capacities that hardly function. In most of these countries, NMRAs have an inadequate number of staff that are insufficiently trained and qualified. Staff turn over is high due to low salaries and lack of incentives. In addition, funding is inadequate and unsustainable, infrastructure is weak, and access to independent and objective medicine information is lacking.
Consequently, in many of these countries medicines are imported without any quality assurance safeguards, while those manufactured locally are produced and distributed under deficient manufacturing and distribution conditions. Moreover, medicines are smuggled in and out of the countries and sold in open market places and on streets, leading to a high prevalence of sub-standard and counterfeit medicines. Reports indicate that in sub-Saharan Africa, on the average, as much as 30% of samples of medicines tested fail quality tests. A recent study carried out by WHO showed that more than 50% of samples failed quality tests. In some countries, the prevalence of counterfeit medicines is estimated at 60% of the medicines found in market places.
WHO has been supporting sub-Saharan African countries to establish and strengthen their national medicine regulatory and quality assurance systems for a long time. More specifically, in the past 10 years, WHO in collaboration with other development partners, has organized several training courses and supported the participation of a large number of medicine regulatory officers in conferences and workshops. In addition, a number of initiatives were undertaken to stimulate regional and subregional collaboration in order to complement these activities.
In 2003, WHO initiated a special scheme aimed at providing focused assistance to selected national medicine regulatory authorities, training regulatory officers in the different areas of medicine regulation, promoting subregional medicine regulation harmonization, and establishing centres of excellence for training medicines regulatory officers. For instance, in the last three years, under this
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1.INTRODUCTION
First African Medicines Regulatory Authorities Conference Final Report
scheme, WHO assessed the regulatory systems of six countries in the subregion, identified gaps, developed action plans together with the respective NMRAs and provided financial and technical support to five of them. In addition, it supported existing and new harmonization initiatives and sent out circular letter to countries to express their interest to serve as training centres. The progress made so far under the scheme is encouraging, but a lot more needs to be done to make them operate effectively and efficiently.
In order to discuss the status of medicine regulation in the subregion, identify the weaknesses, strengths and barriers, and to develop strategies that will help improve medicine regulation, a joint PSM-TCM-WHO/AFRO Conference of African Medicine Regulators was held from 30 October–3 November 2005 in Addis Ababa, Ethiopia.
The conference participants were the heads of National Medicine Regulatory Authorities from 33 countries—Angola, Benin, Botswana, Burkina Faso, Cameroon, Chad, Comoros, Republic of Congo, Côte d'Ivoire, Ethiopia, Equatorial Guinea, Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Madagascar, Malawi, Mali, Mozambique, Namibia, Niger, Nigeria, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Tanzania, Togo, Uganda, Zambia and Zimbabwe.
WHO was represented by staff from TCM/WHO, QSM/PSM, IVB/WHO, EDM/AFRO, WHO/AFRO and National Programme Officers (NPOs) of WHO Country Offices of Cameroon, Ethiopia, Senegal, Tanzania and Uganda.
Mr Eshetu Wondemagegnehu, QSM/PSM, briefed participants on why the conference had been called and on the objectives and expected outcomes. He highlighted the current situation of medicines regulation in sub-Saharan Africa, which is characterized by a weak regulation of medicines in the majority of countries, leading to unapproved/unregistered medicines circulating in the market, smuggling of medicines across borders, high prevalence of substandard
1.2 Participants
2. OPENING OF THE MEETING
2.1 Introduction to the conference
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and counterfeit medicines and unapproved/unmonitored activities such as clinical trials, promotion and advertising of medicines as well as poor dispensing of medicines.
Mr Wondemagegnehu also outlined some of the barriers to effective medicine regulation in the Region, which included, among other, weak political support and commitment to establish/strengthen medicine regulatory systems, inadequate numbers of appropriately trained and motivated staff, inadequate and non-sustainable financing, outdated legislation and guidelines, lack of transparency in the decision-making processes and conflict of interest. He outlined the objectives and expected outcomes of the conference as follows:
Overall objectiveTo promote effective medicines regulation in the subregion in order to ensure that medicines used by people in the subregion are safe, efficacious and of good quality.
Specific objectivesDiscuss the medicines regulation situation in sub-Saharan Africa and identify strengths and weaknesses, priority problems and solutions.Develop a five year strategic plan for the subregion to address the problemsIdentify priority activities to be undertaken during the plan period by the Region.Each country represented in the meeting was to develop a national strategic plan by identifying the strengths and weaknesses of its national medicines regulatory system, and solutions to address the problems and.Develop a strategic plan for 2006–2007.
Expected outcomesRecommendations on how best to address the problems of medicines regulation in sub-Saharan Africa to be formulated, discussed and agreed upon.A five-year Regional Strategic Plan be developed and main activities identified, discussed and adopted.Recommendations on how best to promote harmonization of medicine regulation in sub-Saharan Africa to be formulated, discussed and adoptedA two-year National Action Plan to be implemented by each National Medicines Regulatory Authority be developed and submitted.
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2.2 Welcome address
2.3 Official Opening of the Conference
Following the introduction, Dr Nicholas Eseko, Acting WHO Representative, Ethiopia, welcomed participants to Ethiopia and thanked the organizers for choosing Ethiopia as the venue for this important conference. He reminded participants of the special nature of medicines which should not be treated as ordinary commodities and their crucial role in the delivery of health care. He commended WHO for the support it has rendered to many countries in sub-Saharan Africa to establish and strengthen NMRAs. He also noted that although a lot of progress has been made in the subregion with regard to medicines regulation and control, studies have shown that many MRAs in Africa have a low functional capacity and there are still some Member States with no MRAs. This has led to the circulation of sub-standard and counterfeit medicines in the subregion, which is a major public health concern to all Member States.
Dr Eseko appreciated the relevance and timeliness of the conference, which he hoped would go a long way in promoting effective medicines regulation in the subregion. He expressed confidence that the objectives of the conference would be achieved and wished all the participants fruitful deliberations.
The meeting was officially opened by Mr Hailesellassie Bihon, General Manager of the Drug Administration and Control Authority (DACA) of Ethiopia on behalf of the Minister of Health of Ethiopia. In his speech, Mr Bihon, welcomed the participants to the conference and thanked WHO for choosing Ethiopia to host it. He noted that the provision of quality health services is not possible without availability and equitable access to safe, effective and quality medicines. He elaborated on the steps that Ethiopia has taken to implement the National Drug Policy and the special attention the Government of Ethiopia has given to strengthening the pharmaceutical sector, especially witnessed in the growth of the local manufacturing capacity, from one to more than a dozen local pharmaceutical manufacturers in a period of about 10 years.
Mr Bihon told the participants that given the high burden of disease, the low manufacturing capacity and weak medicines regulatory systems in many African countries, MRAs must build strong partnerships among themselves and with their allies to reduce the consequences of the diseases prevalent in the continent and ensure sustainable development for the people. He noted that the lack of effective and strong medicines regulatory systems in Africa posed a challenge in
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ensuring that medicines used by the health services are safe, effective, of good quality and rationally used. To achieve this would require that each country present in the meeting establish and sustain a strong and independent medicines regulatory body.
Mr Bihon thanked WHO for the support given to strengthen the medicines regulatory capacity in Africa in general and to DACA in particular. He expressed hope that the meeting would yield useful results with the benefit of improving the regulatory situation, and therefore contribute to increasing the availability and access to safe, effective, and quality medicines in Africa. With these words, he wished the participants productive and successful deliberations and then declared the meeting officially open.
In her speech, Mrs Malebona Matsoso, Director of the Department of Technical Cooperation for Essential Drugs and Traditional Medicines, (TCM/WHO) noted that in spite of the progress made, the health status of the world's population, especially in Africa, remains a big challenge. The high burden of disease in Africa, with its weak and fragmented health systems continued to pose a serious challenge to the attainment of the Millennium Development Goals (MDGs).
She highlighted the opportunities available through the support of international organizations/partners such as the WHO pre-qualification project and the focus by regional bodies such as the African Union (AU) and the New Partnership for Africa's Development (NEPAD) to strengthen health systems, including the regulation of medicines.
Mrs Matsoso called upon the participants to “do the right things first”—those that demonstrate added value and doing them right with available resources that can help to achieve the broad objectives of improved access to essential medicines. She reiterated WHO's commitment to provide guidance and technical support to Member States in this regard and wished the participants fruitful deliberations during the conference.
The opening ceremony was followed by administrative announcements, self-introduction by participants, approval of the conference programme and election of officers. The following were elected for the different offices:
2.4 Message from WHO/HQ
2.5 Administrative arrangements
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ChairsMrs Margareth Ndomondo Sigonda, Director General, Tanzania Food and Drug Authority (TFDA), TanzaniaDr Maiga D. Minkaila, Director, Division of Medicine and Pharmacy (DMP), Mali
RapporteursDr Wynn Charles Chalira, Registrar, Pharmacy and Poisons Board, MalawiDr Safiatou Ouattara, UEMOA, Burkina Faso
Support groupMr Joseph, Serutoke, NPO, UgandaMs Rose Shiga, NPO, Tanzania Dr Ngono Mballa Rose, NPO, CameroonDr Ngom Mamdou, NPO, Senegal.
The conference was divided into morning and afternoon sessions consisting of plenary and workshop discussions. The plenary sessions entailed presentation of papers followed by discussions.
The participants were divided into two working groups, French and English speaking, to discuss the workshop themes. Each theme was discussed by both groups separately. Findings of the group works were then presented at plenary session for discussion. Simultaneous French and English translations were provided during plenary sessions. A summary of the day's discussions was presented at the plenary meeting of the next day for discussion and agreement.
(Dr Jean-Marie Trapsida, EDM/AFRO)
Dr Jean-Marie Trapsida presented an overview of the medicines regulation situation in sub-Saharan Africa. He outlined the functions of MRAs, which include licensing of persons and companies dealing in medicines, granting of marketing authorization, authorization of clinical trials, inspection of manufacturers and distribution outlets, monitoring the quality and safety of medicines and control of promotion and advertising of medicines.
3. METHOD OF WORK
4. MAIN TOPICS PRESENTED AND DISCUSSED AT PLENARY4.1 Medicine regulation in sub-Saharan Africa: an overview
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He identified some of the major problems affecting medicines regulation in Africa as:
lack of understanding by policy makers on the need to regulatemedicines, leading to inadequate political support and commitment,inadequate legislation and regulations, inadequate structures and staff in terms of numbers, professional diversity and training,low salaries and lack of incentives,inadequate and non-sustainable funding.
He said that these problems result in undesirable consequences such as:
circulation of unregistered, sub-standard and counterfeit medicines in the market,non-GMP compliant manufacturing activities,unapproved/unmonitored activities such as clinical trials, promotions and advertising of medicines.
Dr Trapsida listed the initiatives taken by WHO to strengthen medicine regulation in the Region and the positive outcomes from these interventions as follows:
technical support to promote harmonization efforts in the SADC, UEMOA and EAC subregions, capacity building based on results of assessment of medicine regulatory systems, installation and use of SIAMED, conducting training courses for GMP inspectors and quality control laboratory staff, etc.
He noted that improvements have been made in medicines regulation in some countries where interventions have been based on joint planned activities. He ended his presentation by calling upon the cooperation of all MRAs to improve the medicines regulation situation in Africa.
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4.2 Country initiatives to promote effective medicine regulation
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Ethiopia
(Mr Abraham G. Kahsay)
Medicine regulation was first established legally in the late 1960s as Pharmacy Division under the Ministry of Health of Ethiopia. In 1999, a new structure was created as an independent authority under the name Drug Administration and Control Authority (DACA). It became operational in 2001. DACA reports to a Board. Fifty-five percent of the working budget comes from central treasury, 12% from fees collected for services and the rest comes from development partners. It has one branch office in the southern part of the country and others are to be opened in the near future. The workforce consists of 60 technical and 50 administrative staff.
DACA's scope of activities as defined by Proclamation 176/1999 include the following:
Setting standards of safety, efficacy, quality for drugs and traditional medicines as well as for competence of pharmaceutical organizations.Formulation of policy governing the sector.Preparation of list of drugs and categorization and revision of the list as necessary.Issuance of license to manufacturers, importers, wholesalers, retail outlets, etc.Registration of drugs for human and animal use, medical supplies, equipments, pesticides, etc. Licensing and inspection of pharmacy establishments. Investigation of the quality of drugs, medical equipment, supply, raw materials.Provision of current and unbiased drug information to professionals and the public.Control of drug advertisement and promotion.Issuance of license for clinical trials.
Côte d'Ivoire (Dr Assi-Gbonon Rosalie, Director, DPM)
The Directorate of Pharmaceutical Services (DPM) was created in 1969 and has undergone several changes since then to an authority which is under the Directorate of Health Practices in the Ministry of Public Health and Population from 2002. It has a well-established structure and is fully dependent on financing from the Government.
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The scope of work includes regulation and control of pharmacy practice, drug registration, manufacturing, import and export regulation, control of drug advertising, inspection of pharmaceutical firms, pharmacovigilance activities, control of narcotics and clinical trials. The organization has 11 technical staff and seven administrative staff. It has so far been able to develop various guidelines for the regulation of the pharmaceutical sector (manufacturing, inspections and registration), register all pharmaceutical products on the market, develop the essential drugs list (EDL), carry out inspections including good marketing practices (GMP) and the assessment of counterfeits which are impounded and destroyed.
The Drugs Regulatory Agency (DRA) has several constraints mainly in the area of inadequate infrastructure, transport, human and financial resources. During the next five years, the Directorate of Pharmaceutical Services of Côte d'Ivoire intends to concentrate on creating a legal framework to ensure independence of the DRA, training of staff in all aspects of regulation, pharmacovigilance, public education on the dangers of illicit (street) drug sales, adequately fighting counterfeits and creating a website for the agency.
Democratic Republic of Congo (Mr Franck Biayi Kanumpepa, Director, Directorate of Pharmacy, Medicines and Medicinal Plants)
The Drugs Regulatory Agency of the Democratic Republic\ of Congo was created in 1951. It has undergone several changes to attain its present status of the Directorate of Pharmacy, Medicines and Medicinal Plants, in 2002. It is fully dependent on Government for financing its activities and it operates as a department under the Ministry of Health. The DRA has a very limited budget that makes it very difficult to cover the entire country due to its vast size. It has a well-established structure with various departments (registration, drug control, quality control, cosmetics control and herbal medicines) consisting of a total of 35 technical staff and 37 administrative staff. The main activities include authorization of importation and exportation of medicines, market authorization for medicines, inspection of pharmaceutical outlets and manufacturers, licensing of premises and quality control of medicines.
The DRA has so far managed to register all locally manufactured medicines, and those that are imported into the country. Twenty-five percent of the local manufacturers are compliant to good marketing practices. During the next five years, focus will be on mobilizing resources (both financial and human to carry
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out their work effectively), training of staff in QC, GMP and GDP, and evaluation of the capacity of the Directorate.
Mali (Dr M. Maiga, Director, DPM)
The Directorate of Pharmacy and Medicines (DPM) was created in 2000 (before this, medicines regulatory functions were handled by the Health Inspectorate, the QC Laboratory and the Directorate of Health in the Ministry of Health) with the essential task of coordinating all activities in the pharmaceutical sector and to carry out medicines regulation. The DPM is fully dependent on Government financing but also receives funds for activities from technical partners. It has 11 technical staff and seven support staff and works together with other departments such as the QC Lab, GMP and clinical trials that are in the Ministry of Health.
The DPM's scope of work includes drug registration (human, veterinary and herbal medicines), regulation and certification of pharmacy practice and licensing of premises and manufacturers. The regulatory functions of GMP inspections, clinical trials controls and QC of medicines are carried out by the Inspectorate, Clinical Trials and QC laboratory departments respectively. The DRA of Mali has been able to register all the products imported in the country, create a website (with support from WHO), install a computerized drug registration system (SIAMED), develop guidelines for registration and distribution of medicines, and set up a multisectoral committee for coordination of the fight against the illicit sale of medicines. They still face many challenges due to inadequate staffing, funding and failure to control imports and the illicit sale of medicines in markets/streets. Over the next five years the DRA of Mali will focus on training of inspectors, implementation of regular effective GMP inspections, regulation of medicines' advertisement, regulation of clinical trials and strengthening the National Health Laboratory for QC of biological and medical devices.
Senegal (Dr M. Ngom EDM/NPO on behalf of Pr M. Badiane, Director, DML)
The Drugs Regulatory Agency of Senegal was established as the Department of Pharmacy and Laboratories (DPL) in 2003 and is fully dependent on Government for financing. It has a well-established structure with various departments—Registration, Administration, Narcotics and Psychotropic substances, Monitoring of ADRs, Registration of Pharmacy-related Businesses and Control/Release of vaccines. The DPL is charged with regulating the
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pharmaceutical sector and practice, registration of medicines, quality control of medicines, promoting rational use of medicines, and pharmacovigilance activities. Their major achievements have been recorded in the development of policies, training manuals, guidelines and procedures for the management of medicines, sensitization of health professionals and consumers on rational use of medicines, registration of all imported and locally produced medicines, inspection of pharmaceutical outlets, and development of a website (on-going).
The DPL still has challenges resulting from inadequate funding, lack of personnel, technical equipment and logistics, and control of illicit sale of medicines in markets. Over the next five years, emphasis will be on training of DRA staff in pharmacovigilance, good marketing practices and good distribution practices, mobilizing financial resources, control of the illicit market, and strengthening the quality control and Inspection departments (see also Annex 3.2.6).
Tanzania (Mrs Margareth Ndomondo Sigonda, Director General, TFDA)
The Tanzania Food and Drugs Authority (TFDA) was established in 2003 from the former Pharmacy Board of Tanzania. It is an executive agency under the Ministry of Health, which is responsible for the regulation of food, drugs (including herbal medicines), cosmetics, medical devices and clinical trials. It has 83 staff responsible for control of food, drugs, cosmetics and medical devices in the departments for Inspection and Surveillance, Product Evaluation and Registration, Business Support Services and Laboratory Services.
Their scope of work involves drug registration (including herbal drugs), registration and licensing of pharmaceutical manufacturers, importers, wholesalers and retailers, drug quality control, pharmacovigilance, control of medicines' promotion, advertising and clinical trials.
TFDA has recorded some achievements in developing essential guidelines for drug regulation, a web site, using minilab centres which have been opened throughout the country for primary screening of drugs using GPHF Minilab Kits, establishment of interlinked databases for drug registration, inspection and quality control. The QC lab has been rated good in proficiency testing organized by WHO.
Major gaps still exist in the lack of linkages to zonal offices, inadequate human and financial resources, insufficient laboratory equipment, reference standards and the capacity to carry out method validation and analysis of vaccines. Their
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five-year plan focuses on conducting public education programmes, instituting a quality management system to attain ISO certification, strengthen inspectorate, pharmacovigilance and QC departments, develop in-house capacity to evaluate new chemical entities, develop specific guidelines for regulating vaccines and herbal medicines and combating counterfeit drugs.
Uganda (M. Apollo Muhairwe, Executive Secretary/Registrar, NDA)
Uganda's DRA, the National Drug Authority (NDA) was established to its present status in 1993. Hundred percent of its working budget comes from fees collected against the services it provides. It has four regional offices (two zonal offices are being set up) with a total of 42 technical staff and 30 administrative staff. The NDA is charged with the registration of drugs (includes herbal drugs, food supplements and public health chemicals), licensing of pharmaceutical premises including manufacturing, quality control of drugs, pharmacovigilance and vetting of pharmaceutical promotional materials and activities.
The main achievements have been in the registration of locally produced products (81%) and those imported (94%). The remaining 6% are authorized for importation under a special provision of the law. Another achievement is in the licensing of premises for pharmaceutical operations (55%) of local manufacturers comply with GMP, 80% of importers and wholesalers comply with GDP and 76% of retail outlets comply with NDA regulations. The NDA's major gaps include post-marketing surveillance at the district level and the capacity of the National QC laboratory, which is limited.
During the next five years, focus is set on training staff in QC, expanding the National QC laboratory to perform microbiological analysis, registration of medical devices and control of clinical trials.
Zimbabwe (Mr M.N. Dauramanzi, MCAZ General Manager)
The DRA of Zimbabwe is referred to as the Medicines Control Authority of Zimbabwe (MCAZ) and was established to its present status in 1997 from the Drugs Control Council, which was first established in 1969 under the Ministry of Health and Child Welfare. It is an autonomous body and it reports to the Minister of Health and Child Welfare through a Board. Hundred percent of its working budget is derived from fees collected for services. The MCAZ has one sub-office, 25 technical staff and 27 administrative staff.
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It is charged with the licensing of manufacturers, wholesalers, retail outlets, industrial clinics, dispensing doctors and veterinary surgeons, registration of medicines, inspection of pharmaceutical premises and animal medicines, control of clinical trials and QC of drugs and medical devices.
The MCAZ has been able to develop, print and distribute all the essential guidelines for medicines regulation (currently undergoing review). Furthermore, it has registered all locally produced products, and ensures that the majority of all those involved in pharmaceutical operations are GMP and GDP compliant. However the organ still experiences challenges due to inadequate human and financial resources, lack of legislation to control import and export of drugs, and a weak post-marketing surveillance system for medicines. Over the next five-year period, the MCAZ will focus on updating their legislation, developing capacity to control medical devices, control of complementary medicines, strengthening the information technology unit and post-marketing surveillance, expanding the laboratory services to include complementary medicines analysis, expanding the revenue base and will seek International Accreditation (ISO 17025).
(Mr Eshetu Wondemagegnehu, QSM/WHO)
Mr Eshetu Wondemagegnehu presented a concept paper outlining the path that countries may have to follow in developing their national regulatory systems. He said building an effective medicine regulation is not an easy task since it involves issues that are political, legal and technical in nature. Implementation of medicine regulation requires scientific and technological knowledge and skills, which may not be easy to find in most countries, developing countries in particular. In many countries, problems and issues related to medicines are barely understood by governments and the general public. Consequently, government and public support is minimal. On the other hand, because the regulated firms are better organized, financially strong and have better scientific and technological knowledge and skills, they have better opportunities to apply pressure on politicians to change regulatory decisions.
4.3 Medicines regulation development path: concept for discussion
13First African Medicines Regulatory Authorities Conference Final Report
Mr Wondemagegnehu recommended a phased (step-by-step) approach for countries starting to build a medicine regulatory system and outlined the following main phases:
Preparatory phase—establishing a medicine regulation taskforce to study thesystem and propose activitesConsensus building phaseStructure building phase- Establish a transitional medicine regulatory body—step1- Appoint leaders and create the authority by law—step 2
Implementation phase (4 Steps)
To ensure sustainable development in medicine regulation, countries are required to introduce a regular assessment system into their medicine regulation. Managers of medicine regulation should have a clear vision on which direction they would like to go and the level they would like to achieve within a given period.
(Mrs Malebona Matsoso, Director, TCM/WHO)
Mrs Malebona Matsoso, Director TCM/WHO outlined the different dimensions of medicines regulation, the regulatory barriers which impact on access to medicines, specific regulatory problems, and some possible solutions for improving medicines regulation.
She pointed out some of the regulatory barriers affecting access to medicines. These were identified in a WHO survey of 11 African countries in 2005, and included lack of an enabling environment (legal framework), technical elements (lack of guidelines, registration delays and backlogs, lack of transparency in decision making) and lack of political commitment. According to Mrs Matsoso, these barriers are further compounded by submissions of poor quality and/or insufficient data, unsubstantiated claims and duplicitous marketing of medicines by the pharmaceutical industry in situations where the National Medicines Regulatory Authorities lack adequate numbers of skilled staff and funding to carry out their functions.
§
§§
§
4.4 Revamping medicines regulation to respond to public health priorities
14First African Medicines Regulatory Authorities Conference Final Report
In conclusion, she recommended some regulatory frameworks and structures that can be developed and used as possible solutions to effective medicines regulation, emphasizing that each NMRA should perform self-assessments and develop an institutional development plan. This should take into account the available human and financial resources. She also proposed harmonization as one of the ways in which medicines regulation can be improved through collaboration and sharing of information between different NMRAs within the subregion.
Experiences Southern Africa Development Community harmonization
(Ms Gugu N. Mahlangu)
Ms Gugu Mahlangu presented the experience of harmonization of medicines regulation within the Southern Africa Development Community (SADC). She outlined the historical development of harmonization within the SADC unto the point at which it was firmly placed on its (SADC's ) agenda in 1999. Two working groups—one for the registration of medicines led by South Africa and the other on drugs control led by Zimbabwe—were formed to carry out the work. She noted the political will and commitment availed to the working groups by the member states of SADC, which was mainly based on their need to improve access to medicines in the region. With external support from WHO and DFID, the SADC Member States, led by the Medicines Control Council of South Africa, shared the responsibilities of developing the various guidelines for the different regulatory functions.
Ms Mahlangu highlighted the achievements made so far in drafting and adoption of harmonized application forms and guidelines for registration of medicines, bioequivalence and bioavailability, stability testing, GMP and clinical trials. However, she noted that there are still various challenges that need to be addressed by SADC, which include the publication and implementation of the guidelines, the creation of a sustainable and fully-funded structure to guide the process including appointing a focal person for pharmaceutical issues in the SADC secretariat and the development of regulatory capacity that is consistent with the available resources.
4.5 Medicine regulation harmonization in Africa
15First African Medicines Regulatory Authorities Conference Final Report
East African Community harmonization
Monetary and Economic Union of West Africa harmonization
(Dr Nditonda Chukilizo)
Dr Nditonda Chukilizo gave the experience of the East African Community (EAC) Member States. He outlined the composition of the EAC (Kenya, Uganda, Tanzania) and the conducive legal and institutional framework available through the EAC Treaty of 1999 that provides for areas of cooperation and establishes the organs of the community. The three Member States' Medicines Regulatory Authorities (MRAs) envision ending up with an EAC Food and Drug Regulatory Authority.
He informed the participants that most of the guidelines that have been adopted by the EAC are based on WHO guidelines. The presence of a legally binding treaty between the three Member States of the community, a common language (Kiswahili) and the similar legislation and level of development of the MRAs are positive factors that are greatly enhancing the harmonization efforts of this subregion. Dr Chukilizo enumerated the gaps/challenges still faced by the EAC such as the inadequate capacity of the MRAs, absence of a focal person within the EAC secretariat, inadequate funding leading to limited contacts of technical committees, involvement of members of the EAC in other regional initiatives (SADC, COMESA) and the lumping together of medicines regulation with other activities in the EAC Charter.
(Dr Safiatou Ouattara)
Dr Ouattara presented the experience of medicines regulation harmonization from the Economic and Monetary Union of West Africa (UEMOA). She listed the members as Benin, Burkina Faso, Côte d'Ivoire, Guinea-Bissau, Mali, Niger, Senegal and Togo. She highlighted the factors that have been conducive in the harmonization efforts such as the strong political will in setting up the bloc, the common currency, languages and similar disease patterns across the union.
With WHO support, UEMOA held the first technical meeting of drugs regulatory authorities in March 2003 and drafted a Memorandum of Understanding (MOU) on harmonization of drug regulations. A second technical meeting was called by the UEMOA, followed by the meeting of Ministers of Health who adopted the MOU in August 2004. In January 2005, the Ministers of Finance endorsed the MOU.
16First African Medicines Regulatory Authorities Conference Final Report
UEMOA has since been able to standardize quality control standards, the registration of generics and other medicines and exchange of information within the Union. A planning meeting is scheduled for early 2006 to set up a secretariat that will coordinate:
Validation of quality of medicines
Value Added Tax (VAT) and other taxes on imported medicines and raw materials
Harmonization of registration of pharmacies and pharmacists.
A draft proposal has been prepared by the WHO in order to mobilize funds to enable UEMOA to set up the Secretariat which will handle the harmonization process.
(Mr Ben Botwe)
Mr Botwe presented the harmonization initiative from the Economic Community of West African States (ECOWAS). He identified the challenges faced within ECOWAS as poor/outdated medicines legislation, uncontrolled distribution of medicines including traditional medicines, different languages and cultures, the existence of parallel initiatives within the same bloc (UEMOA) and inadequate funding.
He noted that the bloc has agreed on a vision and mission and identified priority activities to be undertaken which include harmonizing the requirements for drug registration, labelling, inspections and licensing and pharmacovigilance. Support is needed in order to draft common agreements and a Memorandum of Understanding (MOU), perform an assessment of the MRAs, develop a training manual and design a website for the initiative. Mr Botwe ended his presentation by stating that ECOWAS is now seeking support from WHO and WAHO. The West African Pharmaceutical Manufacturers Association (WAPMA) has indicated interest in participating and supporting the initiative.
§
§
§
Economic Community of West African States harmonization
17First African Medicines Regulatory Authorities Conference Final Report
Economic Community of Central Africa States harmonization
International Conference on Harmonization of Technical Requirements for Drug Registration (ICH)
(Dr Peyou Ndi Marlyse)
The presentation by Dr Peyou Ndi Marlyse was on the experiences of Communauté Economique des Etats de l'Afrique Centrale (CEAC). She reported that harmonization was encouraged by efforts to control common diseases within the bloc. Activities included cover national drug policies, adoption of harmonized regulations, improvement of drugs procurement and price controls.
The challenges faced by the group include the setting up of a technical working group to elaborate the priority areas for cooperation (human resource development, quality control, management of donations, improved exchange of information, regulatory and drug procurement procedures), training needs, a common legal framework for scheduling of medicines in particular and performing a baseline situational analysis. The initiative is progressing and the next meeting of CEAC is planned for early 2006.
(Dr Lembit Rago, QSM/PSM)
Dr Lembit Rago presented the set up of ICH, its members and the factors that have contributed to its success. These include ICH addressing primarily new pharmaceutical products, limiting its membership to six parties, and employing a consensus building activity based on the close relationship between the different working groups who review the differences in requirements among the three ICH regions and develop harmonized guidelines for adoption.
ICH members represent the largest pharmaceutical trade block (76% of the world pharmaceutical market) and these countries are also the world leaders in producing innovator products through pharmaceutical research and development (R & D). ICH members benefit through considerable reduction in the duration of approval of products within Member States. Non-ICH members may be invited to ICH meetings as observers while WHO represents the interests of other Member States during ICH meetings.
Dr Rago also outlined the different regulatory paths to assure quality, safety and efficacy of medicines for public health needs in the developing world. These
18First African Medicines Regulatory Authorities Conference Final Report
19
include the WHO pre-qualification project; United States Food and Drug Administration (FDA); tentative approval process for ARVs, the EU Article 58 and other legislative initiatives to approve generics under compulsory license for export (Canada and Norway).
Article 58 of Regulation (European Commission) No 726/20041 establishes a mechanism whereby the European Medicines Agency (EMEA) may give a scientific opinion, in the context of cooperation with WHO, for the evaluation of certain medicinal products for human use intended exclusively for markets outside the Community. He concluded his presentation by reminding participants that the world is moving towards trusting one another based on transparency and understanding of regulations and procedures. This calls for carrying out activities that add value to the patient so as to enable the scarce resources to be of real value to medicines regulation.
Working group discussions presented at plenary on harmonization of medicine regulation in Africa: Strengths and weaknesses
Participants were divided into two working groups and discussed the strengths and weaknesses of MRAs in Africa with regard to harmonizing their medicines regulation. The groups also made proposals on the steps that should be followed to implement harmonization initiatives and the roles of the different stakeholders in the process.
The working groups appreciated the need for harmonization of medicines regulation, which would lead to optimization of resources and expertise within a subregion, uniform implementation strategies with common requirements, guidelines and procedures for medicines regulation and quick access to medicines to support public health. Countries would take advantage of the economies of scale created through the free movement of medicines within larger markets.
The following were identified as the major strengths, weaknesses and barriers for harmonization of medicines regulation within the region. Additionally, necessary steps to carry out the harmonization were proposed.
Implementation
1. http://mednet3.who.int/prequal/2. http://www.fda.gov/bbs/topics/news/2005/NEW01152.html3. http://www.emea.eu.int/pdfs/human/bwp/557904en.pdf
First African Medicines Regulatory Authorities Conference Final Report
Wo
rkin
g g
rou
p f
ind
ings
1.
Exis
tence
of
regi
onal
eco
nom
ic
blo
cks,
EA
C,
SAD
C,
ECO
WA
S, U
EMO
A, C
OM
ESA
, etc
.
2.
Polit
ical
w
ill
thro
ugh
th
e
above
-mentioned
eco
nom
ic
grou
ps.
3.
Exis
ting
initia
tive
s to
lear
n fr
om
e.g
. ASE
AN
, EU
, SA
DC
.
4.
Exis
ting
guid
elin
es:
WH
O, I
CH
.
Str
en
gth
s an
d o
pp
ort
un
itie
s
Barr
iers
1.
Lack
of
info
rmat
ion e
xchan
ge m
ech
anis
ms
e.g
. IT
shar
ed
w
eb
site
s/p
oin
ts.
2.
Diffe
rent l
egi
slat
ions in
diffe
rent c
ou
ntr
ies.
3.
Diffe
rent l
angu
ages an
d c
ultu
res.
4.
Diffe
rent l
eve
ls o
f deve
lop
ment o
f cou
ntr
ies an
d M
RA
s.
Weakn
ess
es
1.
Weak
MR
As w
ith li
mited
hu
man
and
finan
cial
reso
urc
es.
2.
Par
alle
l and
ove
rlap
pin
g har
moniz
atio
n in
itia
tive
s.
3.
Lack
of s
tru
ctu
res to
coord
inat
e h
arm
oniz
atio
n in
itia
tive
s, e
.g. S
ecr
eta
riat
.
4.
Inad
eq
uat
e e
xchan
ge o
f info
rmat
ion a
nd
exp
eri
ence
s.
5.
Lack
of
a co
mm
on u
nd
ers
tand
ing
of
the t
rue m
ean
ing
and
vis
ion/g
oal
s of
har
moniz
atio
n.
6.
Lack
of p
olit
ical
com
mitm
ent.
7.
Lack
of c
om
mitm
ent f
rom
MR
As.
8.
Lack
of s
ust
ainab
le fu
nd
ing.
Ste
ps
to c
arr
y o
ut
harm
on
izati
on
1.
Bu
ild tr
ust
and
com
mitm
ent a
mong
tech
nic
al p
eop
le to
war
ds har
moniz
atio
n.
2.
Secu
re p
olit
ical
com
mitm
ent a
nd
su
pp
ort
.
3.
Car
ry o
ut s
itu
atio
n a
nal
ysis
and
identify
gap
s.
4.
Define th
e v
isio
n a
nd
goal
s of h
arm
oniz
atio
n.
5.
Set u
p a
dm
inis
trat
ive str
uct
ure
s/se
creta
riat
.
6.
Deve
lop
com
mon str
ategi
es.
7.
Deve
lop
com
mon te
chnic
al re
qu
irem
ents
, sta
nd
ard
, gu
idelin
es,
pro
ced
ure
s.
8.
Up
dat
e le
gisl
atio
ns.
9.
Exch
ange
info
rmat
ion.
20
Firs
t A
fric
an M
edic
ines
Reg
ulat
ory
Aut
hori
ties
Con
fere
nce
Fina
l Rep
ort
The w
ork
ing
grou
ps
pro
pose
d t
he f
ollo
win
g ro
les
for
the d
iffe
rent
stak
ehold
ers
:
•Se
cure
go
vern
ment
polit
ical
sup
port
and
com
mitm
ent.
•Se
cure
th
e
will
ingn
ess
an
d
com
mitm
ent o
f tech
nic
al sta
ff
to th
e h
arm
oniz
atio
n p
roce
ss.
•D
iscu
ss a
nd
ad
op
t co
mm
on
re
qu
ir
em
en
ts
a
nd
p
roce
sse
s—w
hat
can
b
e
done t
oge
ther, w
hat
can
be
shar
ed
.
•Se
t u
p a
n a
uto
nom
ou
s M
RA
wit
h
cle
ar
man
date
fo
r m
ed
icin
es re
gula
tion.
•D
eve
lop
a c
apac
ity
bu
ildin
g
pla
n.
Co
un
try
•C
oo
rdin
ati
on
o
f m
em
ber
stat
es.
•S
et
up
a
fu
nc
tio
na
l
Secr
eta
riat
.
•Sh
arin
g an
d
exc
han
ge
of
info
rmat
ion.
•R
ess
ou
rce m
ob
iliza
tion.
•A
dvo
cacy
.
Su
bre
gio
nal gro
up
•Te
chnic
al a
nd
finan
cial
sup
port
.
•A
dvo
cacy
.
Part
ners
•Te
chnic
al su
pp
ort
.
•C
oord
inat
ion
of
par
tners
an
d
pro
cess
es.
•Su
pp
ort
n
etw
ork
ing
am
on
g
MR
As an
d su
bre
gional
gro
up
s.
•D
isse
min
ate
info
rmat
ion
an
d
best
pra
ctic
es
Set
up
sys
tem
s to
fa
cilit
ate s
har
ing
of
info
rmat
ion
(har
ed
-poin
ts, w
eb
site
s).
WH
O
21
Firs
t A
fric
an M
edic
ines
Reg
ulat
ory
Aut
hori
ties
Con
fere
nce
Fina
l Rep
ort
4.6 Effective law enforcement and regulation of distribution
4.7 Ethical practice, conflict of interest, code of conduct in medicine regulation
(Mrs Malebona Matsoso)
Mrs Malebona Matsoso gave a presentation on effective law enforcement and regulation of the distribution chain. She shared with the participants a short video film on the problem of street vendors in Burkina Faso, which highlighted the challenges and complexities of managing medicine distribution channels with respect to illegal/unlicensed premises, unregistered medicines, expired medicines and poor dispensing practices.
Mrs Matsoso emphasized the need for countries to address this problem through a systematic approach and implement strategies, which would improve the procedures for distribution of medicines. Medicine vendors, who provide access to medicines critical in under-served areas, should be empowered through training and licensing so that they can provide good quality services. There is a need to improve coordination with other law enforcement agencies to control and close illegal medicines distribution outlets. She concluded by noting the need to strengthen post-marketing surveillance and sensitization of communities against the dangers of obtaining medicines from illegal/unlicensed outlets.
(Mr Eshetu Wondemagegnehu)
Mr Eshetu Wondemagegnehu's presentation was on the code of conduct/ethical practices and conflict of interest in medicines regulation. He noted that the regulation of medicines is a key societal function that must be managed in the best interests of the public, emphasizing the need for transparency and accountability. He pointed out the two types of interaction that medicine regulators have with stakeholders as:
(a) with the public, patients and consumers, which focuses on education, promotion of awareness and provision of advice and information and characterized by low potential for conflict of interest or corruption, and
(b) with the regulated firms in the course of controlling private activities, provision of services and decision-making where the potential for conflict of interest and corruption is high.
He enumerated several examples of situations where conflict of interest could arise in medicines regulation. These include acceptance of money by MRA staff
22First African Medicines Regulatory Authorities Conference Final Report
to write positive inspection reports, leakage of confidential information from drug registration dossiers to competitors and receipt of gifts to influence regulatory decisions. He cited some causes of this, which include the lack of guidelines and control measures, poor staff remuneration, and the weak rule of law. Corruption has negative effects on medicines regulation as it erodes institutional capacity. This is characterized by disregarding procedures, wasting resources, and hiring or promoting staff with no regard to performance.
Mr Wondemagegnehu concluded his presentation by providing some strategies that can be set up to minimize corrupt practices. Among these would be guidelines on handling of confidential information. Ethical practices must be seen to be practiced in addition to use of external audits and peer review, which must be a part of institutional governance.
Dr Trapsida gave a presentation on the rapid alert system on quality of medicines. He gave the historical background to the initiative, which started in 1997 when WHO convened a meeting of medicines regulation experts in 1997 in Harare, Zimbabwe. A plan of action for quality testing of medicines was developed and the results of these tests would be published and disseminated within the region. He noted that due to some technical difficulties the initiative did not take off as planned.
He proposed areas of information exchange to include reports of counterfeit medicines, adverse drug reactions, registration status of products and manufacturers, and GMP inspection reports. The main requirement for this to take place would be MRAs' access to the Internet and creation of MRA web sites. Information would be collected from WHO, pharmaceutical industry, MRAs and drug quality control laboratories.
Dr Trapsida concluded by calling upon all MRAs to develop web sites in order to facilitate the exchange of information and reiterated WHO's support in this regard.
(Dr Lembit Rago)
Dr Rago presented the framework convention to combat counterfeit medicines. He noted the various aspects of counterfeit medicines that would include an
4.8 Rapid alert system on quality of medicines
4.9 Counterfeit medicines: framework convention
23First African Medicines Regulatory Authorities Conference Final Report
(Dr Jean-Marie Trapsida)
inadequate quantity or lack of active ingredients, and correct or wrong ingredients made with fraudulent intentions. Counterfeiting of medicines is now a major problem throughout the world and since 1985, WHO has taken the lead in addressing it.
He revealed some of the contributing factors to proliferation of counterfeits, which are poorly developed distribution channels where the counterfeits bypass the official/licensed channels. Added to this is the evolution of the Internet and trade liberalization.
Dr Rago emphasized that fighting counterfeits requires the joint efforts of MRA, industry, law enforcement agencies, national regional and global cooperation. An initiative being considered is the establishment of an international convention on counterfeit medicines control along similar lines of those controlling narcotic and psychotropic substances.
Vaccine regulation and monitoring of clinical trials vaccines
(Mrs. Lilana Chocarro, IVB/WHO)
Mrs Lilana Chocarro, IVB/WHO gave a presentation on the regulatory issues for vaccines and clinical trials evaluation. She emphasized the need to sensitize MRAs on the need to regulate the manufacturing and registration of vaccines, conduct post-marketing surveillance of vaccines including recording Adverse Reactions Following Immunization (ARFI) and clinical trials. She reviewed the procedures for evaluation of vaccines and the progress WHO has made in strengthening the regulatory capacity for vaccines in Africa.
Mrs Choccaro informed the participants of the availability of tools and support to countries to improve vaccines regulation including vaccine clinical trials. These include training activities available through the Global Training Network (GTN) and support to develop institutional development plans that can be used for advocacy and resource mobilization for vaccine regulatory activities.
WHO pre-qualification of priority medicines
(Dr Lembit Rago)
Dr Lembit Rago presented an overview of the WHO pre-qualification project including a demonstration on how to access information from the project web
4.10 Current topics
24First African Medicines Regulatory Authorities Conference Final Report
site. He took the participants through the information on pre-qualified products, manufacturers, assessment and inspection reports, and training modules on GMP. This information is all available on the web site.
He advised countries—especially resource-poor MRAs which can consult the lists of pre-qualified medicines for priority diseases—to make use of this information in making their regulatory decisions.
Group work on regulatory gaps of MRAs in sub-Saharan Africa and the development of a five-year regional plan with identified priority activities to promote effective medicines regulation.
Dr Jean-Marie Trapsida then presented the results of an assessment of the medicines regulatory gaps that were identified from a WHO study of six MRAs in the African Region: Ethiopia, Ghana, Mali, Nigeria, Senegal and Tanzania. The purpose of the assessment was to review the existing legal framework as well as the regulatory and control systems. The assessments were carried out in collaboration with national authorities to identify gaps, make recommendations and develop a plan of action on how to address the gaps.
He outlined the methodology used in the assessment, which included a data collection tool that was completed by the MRAs. The assessment team, comprising WHO/HQ, AFRO and an independent consultant reviewed and discussed the information provided with the staff of the MRA as well as with pharmaceutical manufacturers and importers and other stakeholders.
The major gaps identified were an inadequate legal framework for medicines regulation, inadequate MRA structure, staff and office resources such as computers, vehicles, inadequate and non-sustainable financing of medicine regulation activities, weak infrastructure, lack of access to independent and objective information, and lack of management capacity. The lack of cooperation with other law enforcement agencies and no consultation with stakeholders, professional associations, consumer associations, industries and importers were also found to be major problems with the MRAs in the six countries.
The two working groups then presented the results of their group work on the review of medicines regulatory gaps in sub-Saharan Africa. The results are given in the following table.
4. http://mednet3.who.int/prequal/
25First African Medicines Regulatory Authorities Conference Final Report
Str
en
gth
s an
d o
pp
ort
un
itie
sW
eakn
ess
es
Barr
iers
Str
ate
gie
s to
im
pro
ve r
egu
lati
on
•La
ck o
f/an
d i
nad
eq
uat
e l
egi
slat
ion,
regu
lations,
gu
idelin
es,
SO
Ps
for
all
med
icin
e re
gula
tory
funct
ions.
•In
adeq
uat
e sta
tus/
stru
ctu
re o
f the M
RA
.
•In
adeq
uat
e n
um
bers
of s
kille
d sta
ff.
•In
adeq
uat
e r
eso
urc
es
and
logi
stic
s: c
om
pu
ters
, finan
ces,
sto
rage
sp
ace f
or
doss
iers
and
sam
ple
s, v
ehic
les.
•In
adeq
uat
e
inst
itu
tional
lin
k ag
es
betw
een
the
diffe
rent
regu
lato
ry
funct
ions.
•La
ck o
f ad
eq
uat
e p
riori
tiza
tion/r
isk-
bas
ed
ap
pro
ach.
•La
ck o
f cod
e o
f cond
uct
and
tran
spar
ency
sys
tem
s.
•La
ck o
f coop
era
tion b
etw
een sta
kehold
ers
.
•In
adeq
uat
e e
nfo
rcem
ent m
ech
anis
m a
nd
san
ctio
ns.
•In
adeq
uat
e sensi
tiza
tion o
f the p
ub
lic a
nd
oth
er s
take
hold
ers
.
•In
adeq
uat
e g
uid
elin
es fo
r phar
mac
ovi
gila
nce
.
•In
adeq
uat
e a
pp
reci
atio
n o
f im
port
ance
of e
ffect
ive m
ed
icin
e re
gula
tion.
•Ta
ke g
rad
ual
, feas
ible
and
real
istic
step
s to
war
ds re
gula
tion.
•R
evi
ew
and
str
engt
hen le
gisl
atio
n.
•Pu
t in p
lace
an a
pp
rop
riat
e str
uct
ure
to su
pp
ort
eff
ect
ive re
gula
tion.
•R
evi
ew
and
deve
lop
/str
engt
hen r
egu
lations,
gu
idelin
es
and
pro
ced
ure
s to
sup
port
regu
lation.
•Es
tab
lish m
ech
anis
ms to
ensu
re fi
nan
cial
su
stai
nab
ility
of M
RA
s.
•Se
t u
p a
mech
anis
m t
o e
nsu
re r
ecr
uitm
ent,
tra
inin
g an
d m
ainte
nan
ce o
f
adeq
uat
e h
um
an re
sou
rce (n
um
bers
and
ski
lls).
•Pu
t in p
lace
ad
voca
cy str
ategi
es fo
r eff
ect
ive d
rug
regu
lation.
•Im
pro
ve I
EC/s
ensi
tiza
tion o
f st
akehold
ers
/pu
blic
/civ
il so
cieties
to a
pp
reci
ate
and
su
pp
ort
eff
ect
ive d
rug
regu
lation.
•Se
t up
sys
tem
s fo
r man
agin
g an
d m
ech
anis
m fo
r shar
ing
info
rmat
ion.
•Pu
t in
pla
ce m
ech
anis
ms
for
monitori
ng
and
eva
luat
ion o
f im
ple
menta
tion o
f
dru
g re
gula
tion.
•Ex
iste
nce
of s
om
e le
gisl
atio
n fo
r regu
lation.
•Ex
iste
nce
of s
om
e re
gula
tory
str
uct
ure
s of v
ario
us st
rengt
hs.
•Ex
iste
nce
of s
om
e sta
ff to
perf
orm
som
e re
gula
tory
funct
ions.
•Ex
iste
nce
of
refe
rence
s an
d n
orm
s fr
om
WH
O (
op
port
unity)
Exi
stence
of
har
moniz
atio
n
initia
tive
s an
d
incr
eas
ing
coop
era
tion
betw
een
som
e
cou
ntr
ies.
•In
eff
ect
ive li
censi
ng
of p
rem
ises an
d a
ctiv
itie
s.
•In
adeq
uat
e m
arke
t contr
ol.
•U
nre
gist
ere
d p
rod
uct
s on th
e m
arke
t.
•La
ck o
f tra
nsp
arency
in re
gist
ration sys
tem
s/p
ract
ices.
•In
adeq
uat
e a
ccess
to Q
C L
abs to
su
pp
ort
regi
stra
tion.
•Poor i
nsp
ect
ion p
ract
ices.
•Poor c
od
e o
f cond
uct
– c
orr
up
tion.
•D
up
licat
ion a
nd
conflic
t betw
een sta
kehold
ers
..
•U
neth
ical
pro
motion p
ract
ices.
•B
iase
d/inac
cura
te in
form
atio
n to
the p
ub
lic a
nd
heal
th w
ork
ers
.
•U
nre
gula
ted
clin
ical
tri
als
and
poor
coord
inat
ion a
mong
inst
itu
tions
invo
lved
in re
gula
tion o
f clin
ical
tria
ls.
•N
on-e
xist
ence
/weak
PM
S/p
har
mac
ovi
gila
nce
sys
tem
s.
•La
ck
of/
and
in
adeq
uat
e
com
mu
nic
atio
n
stra
tegy
to
su
pp
ort
eff
ect
ive
regu
lation a
nd
behav
ior c
han
ge.
•W
eak
str
uct
ure
s/st
atu
s of M
RA
in th
e G
ove
rnm
ent.
26
Firs
t A
fric
an M
edic
ines
Reg
ulat
ory
Aut
hori
ties
Con
fere
nce
Fina
l Rep
ort
The g
rou
ps
also
id
entified
the r
ole
s fo
r eac
h p
artn
er
in a
dd
ress
ing
the a
bove
-mentioned
regu
lato
ry g
aps:
§P
ut
in
pla
ce
a
pp
rop
ria
te
legi
slat
ion.
§Se
t u
p an
d su
pp
ort
ap
pro
pri
ate
stru
ctu
re o
f MR
A.
§Es
tab
lish a
nd
su
pp
ort
su
stai
nab
le
fin
anci
ng
mech
anis
ms
for
the
MR
As.
§Sp
ear
head
p
olit
ical
su
pp
ort
fo
r d
rug
regu
lation.
§Su
pp
ort
har
moniz
atio
n a
nd
pu
t in
p
lace
a
cond
uci
ve
envi
ronm
ent
for h
arm
oniz
atio
n.
§Pu
t in
p
lace
m
ech
anis
ms
for
monitori
ng
and
eva
luat
ion.
Go
vern
men
t
§In
itia
te p
roce
ss fo
r re
view
ing
and
st
rengt
henin
g le
gisl
atio
n w
ith h
elp
of M
OH
and
par
liam
ent.
§P
rop
ose
to
go
ve
rnm
en
t/M
OH
ap
pro
pri
ate str
uct
ure
s fo
r the M
RA
.
§R
evi
ew
and
cre
ate r
eal
istic
stra
tegi
c p
lans.
§R
evie
w/s
tre
ngth
en
re
gu
lati
on
s,
guid
elin
es,
SO
Ps.
§Pu
t in
m
ech
anis
ms
for
finan
cial
su
stai
nab
ility
.
§P
re
pa
re
h
um
an
re
so
urc
e
deve
lop
men
t p
oli
cy
an
d
pla
n
(recr
uitm
en
t,
trai
nin
g,
rete
ntio
n,
rem
unera
tion).
§IE
C/a
dvo
cacy
fo
r ap
pre
ciat
ion
of
and
su
pp
ort
for d
rug
regu
lation.
§W
ork
to
war
ds
har
moniz
atio
n
of
regu
lation.
MR
As
§Su
pp
ort
deve
lop
ment o
f ap
pro
pri
ate
legi
slat
ion a
nd
MR
A str
uct
ure
.
§Su
pp
ort
deve
lop
ment of re
gula
tions,
gu
idelin
es,
SO
Ps.
§Su
pp
ort
trai
nin
g of M
RA
sta
ff.
§A
dvo
cate
fo
r ad
eq
uat
e
finan
cing
mech
anis
ms fo
r MR
As.
§Su
pp
ort
MR
As/
cou
ntr
ies
in r
eso
urc
e
mob
iliza
tion m
ech
anis
m t
o s
up
port
m
ed
icin
e re
gula
tion.
§P
rovi
de
tech
nic
al
ass
ista
nce
to
fa
cilit
ate s
trengt
henin
g of
med
icin
e
regu
lation.
§Su
pp
ort
mech
anis
ms fo
r exc
han
ge o
f in
form
ati
on
b
etw
een
co
un
trie
s:
web
site
, e-m
ail, a
nd
meetings
.
§Su
pp
ort
re
gio
nal
harm
on
izati
on
in
itia
tive
s.
Go
vern
men
t
27
Firs
t A
fric
an M
edic
ines
Reg
ulat
ory
Aut
hori
ties
Con
fere
nce
Fina
l Rep
ort
5. DEVELOPMENT OF THE REGIONAL STRATEGIC PLAN
The main objective of the conference was to prepare a five-year regional strategic plan. It was recommended that the two-year national plans be finalized later and submitted by each Medicines Regulatory Authority (MRA).
Mr Eshetu Wondemagegnehu presented an overview of the WHO MRA evaluation tool. The tool collects information in six parts as follows:
(a) the general information on the country and MRA,
(b) organization of the MRA,
(c) the legislation and regulatory system,
(d) human resources management,
(e) strategic plan for institutional development and
(f) other regulatory functions.
Dr Jean-Marie Trapsida then introduced the participants to the group work for the development of the regional strategic plan 2006–2010. Participants were also requested to identify priority activities to be undertaken during this period.
The workplans developed by two groups were presented and discussed in a plenary session. The participants thereafter adopted one consolidated plan with priority activities as shown in the following table:
28First African Medicines Regulatory Authorities Conference Final Report
REG
ION
AL
PLA
N T
O P
RO
MO
TE M
ED
CIN
ES R
EG
ULA
TIO
N I
N W
HO
/AFR
O R
EG
ION
(2
00
6–2
01
0)
Pro
ble
m t
o b
e a
dd
ress
ed
O
bje
ctiv
e
Main
str
ategy/
ap
pro
ach
M
ain
act
ivit
y (i
es)
-WH
O/A
FRO
Inap
pro
pri
ate
lega
l st
atus
of
nat
ional
m
ed
icin
e
regu
lato
ry
auth
ori
ties
to
carr
y ou
t th
eir
re
gula
tory
fu
nct
ions.
To
mak
e
nat
ional
m
ed
icin
e
regu
lato
ry
auth
ori
ties
auto
nom
ous.
Esta
blis
h a
uto
nom
ou
s m
ed
icin
es
regu
lato
ry a
uth
ori
ties
as a
sin
gle
stru
cture
fo
r im
pro
ved
p
erf
orm
ance
.
Ass
ist
countr
ies
in s
ubm
itting
a p
rop
osa
l to
nat
ional
go
vern
ments
for
the c
reat
ion o
f au
tonom
ous
NM
RA
.
Ass
ist
in th
e
pre
par
atio
n d
ocu
ments
th
at p
rovi
de
auto
nom
y to
the N
MR
A.
Pro
vid
e a
ssis
tance
to N
MR
A t
o m
ake t
he r
egu
lato
ry
funct
ion e
ffect
ive.
Sup
port
in initia
ting
con
sultat
ive c
om
mis
sions.
Inad
eq
uat
e
hum
an
reso
urc
es.
To
d
eve
lop
th
e
cap
acity
of
hum
an
reso
urc
es.
Trai
nin
g of
MR
A s
taff.
P
rom
otion
of
exc
han
ge
of
exp
ert
ise b
etw
een c
ountr
ies
and
p
oolin
g of
exp
ert
ise in t
he R
egi
on.
U
se
tech
nic
al
assi
stan
ce
from
outs
ide t
he R
egi
on.
Pro
vid
e t
rain
ing
in:
- p
rod
uct
regi
stra
tion.
- in
spect
ion-G
MP.
- q
ual
ity
contr
ol.
- p
har
mac
ovi
gila
nce
.
- co
ntr
ol of
clin
ical
tri
als.
- G
CP.
- m
anag
em
ent
(of
MR
As)
.
- eff
ect
ive c
om
munic
atio
n.
Cre
ate d
atab
ase o
n e
xpert
ise w
ithin
the R
egi
on.
SWO
T a
nal
ysis
for
hum
an r
eso
urc
es.
Org
aniz
e t
rain
ing
of
trai
ners
(T
OT).
Org
aniz
e d
iscu
ssio
n f
ora
.
Arr
ange
exc
han
ge o
f w
ork
ing
visi
ts.
Identify
tech
nic
al a
ssis
tance
with a
goal
to d
eve
lop
nat
ional
cap
acity.
Inad
eq
uat
e l
egis
lation a
nd
re
gula
tions.
To d
eve
lop
, re
vise
and
up
dat
e
legi
slat
ion/
regu
lations.
Ad
voca
cy
for
com
pre
hensi
ve,
stro
ng
legi
slat
ion a
nd
regu
lations.
Cond
uct
ass
ess
ment
of
legi
slat
ion.
Pro
vid
e m
od
el le
gisl
atio
n.
Pro
vid
e
tech
nic
al
and
finan
cial
su
pp
ort
to
d
eve
lop
/revi
se/u
pd
ate legi
slat
ion a
nd
regu
lations.
29
Firs
t A
fric
an M
edic
ines
Reg
ulat
ory
Aut
hori
ties
Con
fere
nce
Fina
l Rep
ort
30
Firs
t A
fric
an M
edic
ines
Reg
ulat
ory
Aut
hori
ties
Con
fere
nce
Fina
l Rep
ort
Weak
in
form
atio
n
man
agem
ent
syst
em
an
d
lack
of
acce
ss
to
ind
ep
end
ent
info
rmat
ion.
To
build
in
form
atio
n
man
agem
ent
and
exc
han
ge s
yste
m.
To
imp
rove
ac
cess
to
in
dep
end
ent
info
rmat
ion.
Str
engt
hen
sy
stem
s fo
r in
form
atio
n
man
agem
ent
and
exc
han
ge.
Cre
ate a
ccess
to I
nte
rnet.
Cre
ate
an
info
rmat
ion
dat
abas
e:
Regi
onal
sh
ared
p
oin
ts.
Sup
port
exc
han
ge o
f in
form
atio
n w
ithin
the r
egi
on.
Deve
lop
mod
el so
ftw
are a
nd
websi
te d
esi
gn.
Sup
port
countr
ies
to h
ave w
ebsi
te,
dat
abas
es
and
IT
syst
em
s/har
dw
are.
Trai
n c
ountr
ies
in info
rmat
ion m
anag
em
ent.
Deve
lop
to
ols
fo
r IE
C
and
behav
iour
chan
ge
for
eff
ect
ive d
rug
regu
lation.
Inad
eq
uat
e
tools
—gu
idelin
es,
p
roce
dure
s,
SO
Ps
not
fully
deve
lop
ed
.
To re
view
, re
vise
an
d
deve
lop
tools
.
To
tran
slat
e
WH
O
tools
into
oth
er
WH
O
langu
ages
and
d
istr
ibute
th
em
to
co
untr
ies.
Pro
vid
e
tech
nic
al
assi
stan
ce
to
deve
lop
tools
.
Pro
vid
e m
od
el
tools
to c
ou
ntr
ies
to a
dop
t or
adap
t th
em
.
Identify
ess
ential
tools
for
good
regu
lato
ry p
ract
ice.
Faci
litat
e
deve
lop
ment,
ad
op
tion,
adap
tation
and
im
ple
menta
tio
n
of
mod
el/har
moniz
ed
to
ols
(b
est
p
ract
ices
within
the R
egi
on).
Tran
slat
e e
xist
ing
tool in
to o
ther
WH
O lan
guag
es.
Lac
k of
tech
nic
al
coop
era
tion
netw
ork
ing
betw
een M
RA
s.
To
est
ablis
h
and
st
rengt
hen
regi
onal
an
d
subre
gional
har
moniz
atio
n
and
netw
ork
ing.
To c
reat
e a
regi
onal
d
iscu
ssio
n f
oru
m.
Su
pp
ort
regi
onal
and
su
bre
gional
har
moniz
atio
n initia
tive
s.
Ad
voca
te
for
har
moniz
atio
n
at
the r
egi
onal
eco
nom
ic b
locs
.
Cre
ate a
nd
sup
port
dis
cuss
ion f
ora
.
Fost
er
har
moniz
atio
n b
y usi
ng
WH
O i
nte
r-re
gional
st
ruct
ure
s an
d r
egi
onal
blo
cs.
Inad
eq
uat
e f
und
ing
To
cr
eat
e
adeq
uat
e
and
su
stai
nab
le
fund
ing
syst
em
fo
r M
RA
s.
Enco
ura
ge/a
dvo
cate
str
ategi
es
for
sust
ainab
le f
und
ing.
Ensu
re
that
th
ere
is
fu
nd
ing
ded
icat
ed
to
med
icin
es
regu
lation/M
RA
s.
Deve
lop
pro
ject
s to
mobili
ze f
und
ing.
Ad
voca
te
for
ded
icat
ed
fu
nd
ing
from
re
gional
eco
nom
ic b
locs
for
med
icin
es
regu
lation.
Ad
vise
countr
ies
on m
ech
anis
ms
to g
enera
te f
und
ing
for
MR
As.
Pro
ble
m t
o b
e a
dd
ress
ed
O
bje
ctiv
e
Main
str
ate
gy/
ap
pro
ach
M
ain
act
ivit
y (i
es)
-WH
O/A
FR
O
Inad
eq
uat
e
imp
ort
an
d
exp
ort
contr
ols
.To
st
rengt
hen
imp
ort
an
d e
xport
contr
ols
.P
rom
ote
/su
pport
co
op
era
tion
and
co
ord
inat
ion
betw
een
countr
ies,
MR
As,
Cu
stom
s, o
ther
agenci
es.
Faci
litat
e a
foru
m fo
r d
iscu
ssio
n betw
een re
leva
nt
agenci
es.
Pro
vid
e m
od
el ce
rtific
atio
n s
yste
ms.
Sup
port
rele
vant
trai
nin
g in
contr
olli
ng
imp
ort
and
exp
ort
of
med
icin
es.
Stre
ngt
hen
legi
slat
ion
and
re
gula
tions
to
faci
litat
e
eff
ect
ive c
ontr
ol of
imp
ort
and
exp
ort
of m
ed
icin
es.
Weak
mar
ket
contr
ol.
To
stre
ngt
hen
mar
ket
contr
ol.
Deve
lop
st
rate
gies
for
enfo
rcem
ent
of
good
dis
trib
ution
pra
ctic
es
(GD
P)
and
m
arke
t co
ntr
ol.
Stre
ngt
hen
p
ost
-mar
keting
surv
eill
ance
bas
ed
on
risk
m
anag
em
ent.
Ad
voca
te f
or
GD
P a
nd
hig
hlig
ht
dan
gers
of
poor
mar
ket
contr
ols
an
d p
ract
ices.
Help
countr
ies
imp
lem
ent
and
enfo
rce G
DP.
Pro
vid
e
sup
port
fo
r in
nova
tive
an
d
alte
rnat
ive
dis
trib
ution
syst
em
s w
ithout
loosi
ng
sigh
t of
stre
ngt
hen
ing
conve
ntional
sys
tem
s.
Sup
port
com
munity
mobili
zation a
ctiv
itie
s to
sup
port
eff
ect
ive m
arke
t co
ntr
ols
.
Exis
tence
of
cou
nte
rfeit
pro
du
cts
on
nat
ional
m
arke
ts.
To
creat
e
eff
ect
ive
syst
em
s fo
r co
mbat
ing
counte
rfeit m
ed
icin
es.
Ad
voca
te
and
su
pp
ort
st
rate
gies
for
com
bat
ing
counte
rfeit
med
icin
es.
Trai
nin
g in
d
ete
ctio
n
and
id
entifica
tion
of
counte
rfeit
med
icin
es.
Cre
ate R
apid
Ale
rt S
yste
m (
RA
S)
for
exc
han
ge o
f in
form
atio
n.
Put
in p
lace
a s
yste
m f
or
dete
ctio
n a
nd
shar
ing
of
info
rmat
ion o
n c
ounte
rfeit m
ed
icin
es.
Sup
port
th
e p
artici
pat
ion
of
countr
ies
in
inte
rnat
ional
meetings
.
Sup
port
the p
oss
ibili
ty o
f est
ablis
hin
g a
conve
ntion
on c
ounte
rfeit m
ed
icin
es.
31
Firs
t A
fric
an M
edic
ines
Reg
ulat
ory
Aut
hori
ties
Con
fere
nce
Fina
l Rep
ort
Pro
ble
m t
o b
e a
dd
ress
ed
O
bje
ctiv
e
Main
str
ategy/
ap
pro
ach
M
ain
act
ivit
y (i
es)
-WH
O/A
FRO
Loca
l p
rod
uct
ion
firm
s non-c
om
plia
nt
with G
MP
(A
RV
s,
anti-m
alar
ial
and
an
ti-T
B m
ed
icin
es)
.
To
enhan
ce
GM
P
com
plia
nce
by
loca
l m
anufa
cture
rs.
Pro
vid
e
tech
nic
al
assi
stan
ce
to
MR
As
and
ind
ust
ry o
n G
MP.
Ass
ess
dom
est
ic p
rod
uct
ion c
apac
ity.
Pro
vid
e
tech
nic
al
assi
stan
ce—
trai
nin
g in
G
MP
to
M
RA
and
ind
ust
ry s
taff.
Ad
voca
te
for
GM
P
com
plia
nce
am
ong
ind
ust
ry
asso
ciat
ions
to p
rom
ote
self-r
egu
lation.
Faci
litat
e e
xchan
ge o
f exp
ert
ise b
etw
een M
RA
s an
d
ind
ust
ries.
Deve
lop
a
tool
to
asse
ss
feas
ibili
ty
of
loca
l p
rod
uct
ion a
nd
fac
ilita
te s
trengt
henin
g of
regu
lato
ry
cap
acity
in t
he R
egi
on.
Weak
q
ual
ity
contr
ol
lab
ora
tori
es.
To
stre
ngt
hen
QC
la
bora
tori
es.
Re-e
quip
pin
g la
bora
tori
es.
Stre
ngt
hen
QC
m
anag
em
ent
syst
em
s.
Ass
ist
the r
e-e
quip
ment
of
QC
lab
s an
d i
n a
cquir
ing
refe
rence
sta
nd
ard
s.
Ass
ist
QC
lab
s to
put
in p
lace
qual
ity
man
agem
en
t sy
stem
s.
Sup
port
ISO
17
02
5 a
ccre
ditat
ion o
f Q
C la
bs.
MR
As
not
regu
lating
all
cate
gori
es
of
pro
du
cts
subje
ct t
o r
egu
lation (
e.g
. tr
aditio
nal
an
d
com
ple
menta
ry m
ed
icin
e,
bio
logi
cal
pro
duct
s,
med
ical
devi
ces
etc
.).
To s
trengt
hen M
RA
s to
enab
le
them
re
gula
te
all
cate
gori
es
of
pro
duct
s su
bje
ct
to
regu
lation.
Revi
se
legi
slat
ion
to
cove
r al
l p
rod
uct
s.
Stre
ngt
hen
regu
lato
ry
syst
em
to
co
ntr
ol al
l p
rod
uct
s.
Pro
vid
e t
ech
nic
al s
up
port
in r
evi
sing
legi
slat
ion.
Inad
eq
uat
e
regu
lation
of
clin
ical
tri
als.
To
stre
ngt
hen
regu
lation
of
clin
ical
tr
ials
.
Deve
lop
to
ols
fo
r re
gula
tion
of
clin
ical
tri
als.
Trai
nin
g M
RA
s st
aff.
Pro
vid
e s
up
port
in t
he d
eve
lop
ment
of
tools
.
Trai
n
MR
A
staf
f in
cl
inic
al
tria
l co
ntr
ol
and
m
onitori
ng.
32
Firs
t A
fric
an M
edic
ines
Reg
ulat
ory
Aut
hori
ties
Con
fere
nce
Fina
l Rep
ort
Pro
ble
m t
o b
e a
dd
ress
ed
O
bje
ctiv
e
Main
str
ategy/
ap
pro
ach
M
ain
act
ivit
y (i
es)
-WH
O/A
FRO
6. RECOMMENDATIONS
Based on the various discussions during the meeting, the following recommendations were made:
Recommendations to MRAs
§Develop and implement strategies to promote effective medicines regulation.
§Prepare and submit to WHO/AFRO a two-year national plan indicating the priority activities to be undertaken in 2006–2007 to improve medicines regulation.
§Explore regional collaboration and support the creation of networks to share information on medicines regulation.
Recommendations to governments
§Support medicines regulation and provide adequate funds to MRAs to perform their functions.
§Advocate for and support subregional and regional harmonization initiatives.
§Support human resources development for medicines regulation.
§Institutionalize the development and strengthening of autonomous MRAs.
Recommendations to WHO
§To further the exchange of information and experiences of medicines regulation in the region, it was recommended that WHO/AFRO organize a conference for all African Medicines Regulatory Authorities at least once every two years.
§Ensure better coordination of medicines regulatory activities in the region.
§Advocate for countries to establish MRAs and adequately fund medicines regulation.
§Strengthen and expand MRA assessments to other countries in the region.
§Support capacity building and training of MRA staff.
§Ensure that all existing tools and documents are available in both English and French.
§Promote the exchange and use of technical expertise available in the region.
33First African Medicines Regulatory Authorities Conference Final Report
7. CLOSING CEREMONY
The conference was officially closed by Mrs Malebona Matsoso, Director of the Department of Technical Cooperation for Essential Drugs and Traditional Medicines, WHO (TCM/WHO). In her closing remarks, Mrs Matsoso thanked and congratulated the participants for a successful meeting, especially the conference chairpersons and rapporteurs for the excellent work done. She noted with satisfaction that the objectives of the conference had been achieved and hoped that this was the beginning of the process to strengthen medicines regulation in the region.
Mrs Matsoso appreciated the enriching discussions and experiences that were shared by participants during the course of the meeting and was confident that these lessons would be taken back home to improve medicines regulation in their respective countries.
She reiterated WHO's commitment and unwavering support to improve medicines regulation in the countries and continued advocacy. She informed participants that WHO would be celebrating 30 years of the Essential Medicines Concept in 2007. Her department intends to use the occasion to profile the exceptional work that has so far been done in this field through improving access to essential medicines, and medicines regulation.
Mrs Matsoso thanked the participants once again for the work accomplished during the conference and wished them a safe journey home. After these remarks, the meeting was declared officially closed.
Speaking earlier, the conference co-chair, Dr Maiga Minkaila thanked WHO for organizing the conference, and the Government of Ethiopia for hosting it. He noted with appreciation the enormous work that was accomplished during the four-day duration and was confident that when the recommendations are implemented, they will go a long way in improving the situation of medicines regulation in the region. On behalf of the conference chairs and the participants, he thanked the rapporteurs and interpreters for their admirable work.
Dr Safiatou Ouattara offered a vote of thanks to the conference hosts, organizers, and participants.
34First African Medicines Regulatory Authorities Conference Final Report
ANGOLAMr Daniel AntonioTel: +244-222-320030Fax: + 244-222-328166e-mail: [email protected]
BENINDansou AlfredTel: +229-90903298Fax: +229-330882e-mail: [email protected]
BOTSWANADr Sinah SeleloTel: +267-3-632064Fax: +267-3-180870e-mail: [email protected]
BURKINA FASODr Amadou KoumareTel: +226-50324660 / 70250915Fax: -+226-50314476e-mail: akoumare2002 @yahoo.fr
Dr. Ouattara SafiatouTel: +226-50324660Fax: +226-50314476e-mail: [email protected]
CAMEROONDr Ngono Mballa RoseTel: +237-221-0259Fax: +237-221-1077e-mail: [email protected]
OCEACDr Peyou Ndi MarlyseTel: +237-616-4932Fax: +237-223-0061e-mail: [email protected]
CHADDr Ahmat Ali HisseinTel: +235-517566Fax: +235-517566e-mail: [email protected] or [email protected]
COMOROSDr Said Omar Said HamidouTel: +269-731-264 / 269-330-480Fax: +269-731-724e-mail: [email protected]
REPUBLIC OF CONGODr Gondzia Guy PatrickTel: +242-810-542 / 662-3525Fax: +242-810-543e-mail: [email protected]
CÔTE D'IVOIREDr Rosalie Assi GbononTel: +225-213-57313Fax: +225-213-56958e-mail: [email protected]
EQUATORIAL GUINEAMr Mocong Mate RafaelTel: +240-2-51305e-mail: [email protected]
ETHIOPIAMr Abraham G. Giorgis KahsayTel: + 251-115-524116Fax: +251-111-5521392e-mail: [email protected]
GAMBIAMrs Fatoumata I.N JahTel: +220-4-225374Fax: +220-4-225873e-mail: [email protected]
ANNEX: LIST OF PARTICIPANTS
35First African Medicines Regulatory Authorities Conference Final Report
GHANAMr E. Kyeremateng AgyarkoTel: +233-2-1660489Fax: +233-2-1660389e-mail: [email protected]
Mr Benjamin Kwame BotweTel: +233-2-1910760Fax: +233-2-1660389e-mail: [email protected]
GUINEADr Bah HarirataTel: +244-4-52028 / 297071Fax: +224-4-52050e-mail: [email protected]
GUINEA-BISSAUMr Pepas Vincente NatakTel: +245-7-206617Fax: +245-7-201188e-mail: [email protected]
KENYAMs Sarah Akoth ChuchuTel: +254-227-21937Fax: [email protected]
MADAGASCARDr Rasoanaivo Nivo HanitraTel: [email protected]
MALAWIDr Wynn Charles ChaliraTel: + 265-1-752652Fax: +265-1-755204e-mail: [email protected]
MALIDr Maiga Minkaila D.Tel: +223-222-6570Fax: +233-223-2463e-mail: [email protected]
MOZAMBIQUEDr Suraia Mussa NanlaTel:+258-21-326547Fax: +258-21-303473e-mail: [email protected]
Dr Tania Vuyeya SitoiTel:+258-213-26547Fax: +258-213-03473e-mail: [email protected]
NAMIBIAMs. Dinah Jorokee TjihoTel: +264-61-2032391Fax: +264-61-234462e-mail: [email protected] or [email protected]
NIGERElhadj Maty MamanTel: +227-722450Fax: +227-733570e-mail: [email protected]
NIGERIAMr Hashim Ubale YusufuTel: +234-9-6709894Fax: +234-9-5241106e-mail: [email protected]
RWANDAMr Munyankinde VedasteTel: +250-5-11270e-mail: [email protected]
SAO TOME AND PRINCIPEDr Marcelina Quaresma J. CostaTel: +239-225942Fax: +239-221306e-mail: [email protected]
SENEGALDr Ngom MamadouTel: +221-8695937Fax: +221-8204314e-mail: [email protected]
36First African Medicines Regulatory Authorities Conference Final Report
SEYCHELLESMrs Aimie TotinTel: +248-388333Fax: +248-323618e-mail: [email protected]
SIERRA LEONEMr Michael Jack LansanaTel: +232-22-229346 / 228497Fax: +232-22-224526e-mail: [email protected] or [email protected]
TANZANIAMr Hiiti Baran SilloTel: +255-744-307179Fax: +255-222-450793e-mail: [email protected]; [email protected]
Ms. Margareth Ndomondo SigondaTel: +255-22-2450 979Fax: +255-22-2450793e-mail: [email protected] or [email protected]
Dr. Nditonda Benno ChukilizoTel: +255-22-2450512Fax: +255-22-2450793e-mail: [email protected] or [email protected]
Ms. Rose ShijaTel: +255-22-2111718Fax: +255-22-2113180e-mail: [email protected]
TOGODr Atany Nyansa (Bernardin)Tel: +228-22-20799 / +228-09-206221Fax:+228-22-20799e-mail: [email protected]
UGANDAMr Apollo MuhairweTel: +256-41-255665Fax: +256-41-255758e-mail: [email protected]
Mr Deusdedit MubangiziTel: +256-41-347391 / 2Fax: [email protected]
Mr Joseph SerutokeTel: +256-41-335500Fax: +256-41-335569e-mail: [email protected]
ZAMBIAMr Felix Peter ChizuTel: +261-1-220429Fax: +261-1-238458e-mail: [email protected]
ZIMBABWEMs Gugu Nolwandle MahlanguTel: +263-4-736981 / 5Fax: +263-4-736980e-mail: [email protected]
Mr Mafios DauramanziTel: +263-736981–5Fax: +263-4-736980e-mail: [email protected]
WHO SECRETARIATMrs. Malebona MatsosoTCM/WHOTel: +41-22-791-1452e-mail: [email protected]
Dr. Lembit RagoQSM/PSMTel: +41-22-791-4420Fax: 41-22-791-4730e-mail: [email protected]
Mrs. Lilana ChocarroIVB/ WHOTel: +41-22-791-1883Fax: [email protected]
37First African Medicines Regulatory Authorities Conference Final Report
Mr. Eshetu WondemagegnehuQSM/PSMTel: +41-22-791-3473Fax: +41-22-791-4730e-mail: [email protected]
Mr Tefera BekeleNPO/WCO, EthiopiaTel: +251-115-44-44-53e-mail: [email protected]
Dr Modibo DickoWHO/AFROTel: +47-241-38200 / +263-11412488e-mail: [email protected]
Dr Jean-Marie TrapsidaEDM/AFROTel: +47 241 39258Fax: +47 241 39511e-mail: [email protected]
38First African Medicines Regulatory Authorities Conference Final Report