Pan American Network on Drug regulatory HarmonizationWG/Medicinal Plants

II Meeting29-31, March

Curitiba, Brazil

Background in the Americas I

– Regional Experts Meeting Jamaica (Nov 2000)

• Requirements for registration of MP• Concept of MP

Regional Experts Meeting (2000)Participants

• Regulators from• Bolivia, Colombia, Cuba, Chile, Ecuador,

Guatemala, Jamaica, Peru & USA

• Other participants:• Rep from MERCOSUR, Industry, WHO

Collaborating Centers & Research Institutes

• WHO and PAHO

Regional Expert Meeting (2000)Confirmed

• There are various form of TRM in the context of different cultures without a parallel development of international standards and effective methods for evaluating traditional medicines.

• Regulation/registration for herbal products and traditional therapies are inadequate in most countries.

• Drug Regulators of the America have expressed to PAHO/WHO their interest to work in the area of HM to develop a harmonized proposal on process and requirements herbal product registration.

Regional Experts Meeting (2000)Objectives

• To discuss issues surrounding production, registration and use of herbal products & to develop a proposal on harmonized standards and regulations to assure safe, safety and quality of products.

• To analyze the main issues on national policy, economic issues and regulation and registration of herbal products & to share the experience on regulation and registration of herbal products.

• To introduce WHO relative guidelines for assessment of safety and efficacy of herbal medicines.

• To discuss and adopt a proposal on common requirements of registration of herbal products.

• To facilitate integration of traditional medicine into national health care system.

Regional Experts Meeting (2000)Outcomes

• A report on the situation on the use of herbal medicine and main issues concerning national policies, economic issues and regulation and registration of herbal product in selected countries,

• A proposal on common requirements will be adopted, and

• A proposed plan of action to follow up conclusions and recommendations of the meeting.

• A report on the situation on the use of herbal medicine and main issues concerning national policies, economic issues and regulation and registration of herbal product in selected countries,

• A proposal on common requirements will be adopted, and

• A proposed plan of action to follow up conclusions and recommendations of the meeting.

Regional Experts Meeting (2000)Recommendations to Countries

1. To adopt the requirements for registration of HM; 2. To establish a national expert advisory committee

with representatives of stakeholders to determine which botanical products are to be subject to registration and regulation and, if necessary, determine which are not medical agents;

3. To promote the inclusion of TRM in the curricula for health professionals, mainly medical schools and, in the meanwhile, to develop special training programs to disseminate TRM concepts and practices among present medical doctors;

4. To establish of an information program on HM to the general public.

Regional Experts Meeting (2000)Recommendations to Countries

5. To establish a specific post marketing surveillance on the use of HM as part of the general drug post marketing surveillance program;

6. To develop standards of good botanical practices to guarantee that each lot of raw material or plant material used to make a herbal drug should be completely identified. The creation of a herbal of reference is to be the responsibility of the manufacturer or supplier of raw material.

Regional Experts Meeting (2000)Recomendations to PAHO

• To develop activities such as seminars, workshops and similar activities for training on specific subjects on herbal medicine such as the implementation of safety, efficacy and quality control;

• The Secretariat of the PANDRH to propose to the Steering Committee of the Network the establishment of a WG on HM. This WG would be coordinated by the NRA Mexico and be integrated with the following Member States which participated at this meeting: – Brazil: Edmundo Machado Neto; Chile: Gonzalo Navarrete;

Canada: Peter Chan; Costa Rica: Sandra Martinez; Guatemala: Judith de Castro; Peru: Enrique León; Mexico: Juan Hernandez; Jamaica: Grace Allen-Young & OECS: Francis Burnett

• This group to be presented at the next Pan American Conference on Drug Regulatory Harmonization;

• WHO should develop Guidelines on good agricultural practice of medicinal plants.

Background (Americas) II

• Establishment of a WG on Medicinal Plants by the III Conference (2002)

Background (Americas) III

• Regional Meeting on MTR to discuss (2003)– Regulation– Quality Control– Safety and Pharmacovigilance

Regional Meeting on MTR (2003)Participants

1. ARGENTINA: Claudia Beatriz Carino2. BOLIVIA: Alberto Giménez Turba3. BRASIL: Edmundo Machado NettoCésar Piniteiro Jacoby4. CANADA: Robin MarlesDuc Vu5. COSTA RICA: Kattia María Rosales6. CHILE: Margarita Alicia Saéz7. EL SALVADOR: Juan Manuel Chicas Vásquez8. ECUADOR: Milton Jijón Arguello9. GERMANY: Konstantin Keller10. HONDURAS: Juan Almendares11. JAMAICA: Princess Thomas Osbourne12. MEXICO: Federico S. Meixueiro Ortiz13. NICARAGUA: Nubia Argentina Blanco Sampson 14. PANAMA: Mahabir Prashad Gupta15. PERU: Carlos Gustavo Del Aguila Campos16. REP. DOMINICANA: Juan Agustín Alcantara Gómez17. U S A: Harry H. S. Fong18. GUATEMALA: Marta de Alvarez & Beatríz de Jiménez• WHO and PAHO

Regional Meeting on MTR (2003)Objectives

• To analyze the status of the national policy in AMRO through country presentations and the preliminary results of the WHO Global survey on Traditional and Complementary/Alternative Medicine;

• To introduce WHO-TRM strategy materials and facilitate discussion on topics recommended from previous meetings, especially those of safety monitoring and quality control;

• To discuss and determine the kinds of technical advice and support needed by the Member States and AMRO on the emerging topics in Traditional and Complementary/Alternative Medicines to be provided by WHO-TRM and AMRO/PAHO.

Regional Meeting on MTR (2003)Outcomes

Recommendations on: • Regulation of HM;(2) Quality control of HM;(3) Safety monitoring of HM;(4) Rational use of traditional medicines; and(5) Challenges for regulatory harmonization

in the field of quality control, safety monitoring and proper use of HM by consumers.

Regional Meeting on MTR (2003)Recommendations

• REGULATORY ASPECTS

• Establish a mechanism of exchange of information among countries on regulation, quality, safety, and rational use of herbal medicines.

• Participating in/Establishing an international network for information exchange.

• Update WHO document “Regulatory situation of herbal medicines: a world wide review”

• Facilitate exchange of information on herbal medicines among Member States through different measures and tools. There is a need for harmonization, from marketing point of view, as different regulatory classifications are given to a same product among countries in the Region.

• Harmonize definition and classification of selective herbal medicines and herbal products in the Region, through the work of the Pan American Working Group on Medicinal Plant.

Regional Meeting on MTR (2003)Recommendations

• QUALITY ASSURANCE (I) • The quality assurance measures should be applied at all the

different stage of production of herbal medicines including: good agricultural and field collection practices (GACP) for medicinal plants, good manufacturing practices (GMP) and post marketing surveillance.

• Review and update of the current national quality assurance system by incorporating measures such as GACP and GMP.

• Consider to develop national GACP guidelines (general guidelines and/or specific guidelines on selected medicinal plants).

• Finalize the draft WHO guidelines on GACP for medicinal plants.

• Provide Technical assistance to the Member States.

Regional Meeting on MTR (2003)Recommendations

• QUALITY ASSURANCE (II) • Need to establish quality standard and specification of

herbal medicines, including identification of marker substances for quality control purpose.

• Preparation of national monographs on native medicinal plants.

• Exchange of information on existing national monographs on medicinal plants in the Region.

• Establish and strengthen research collaboration with research institutions and universities, required for quality control of herbal medicines.

• Finalize the draft updated supplement GMP for herbal medicines.

• Develop new technical guidelines relating quality assurance and control of herbal medicines, including possible marker substances for quality control purpose.

Regional Meeting on MTR (2003)Recommendations

• QUALITY CONTROL• Strengthen the national reference

laboratories capacity for quality control of herbal medicines.

• Training of personnel of the national quality control laboratories.

• Provide technical guidance on analytical methods of herbal medicines required at the national quality control laboratories.

Regional Meeting on MTR (2003)Recommendations

• SAFETY • Define the strategy of approach in order to establish the

national program on safety-, monitoring of herbal medicines.• Strengthening participatory processes.• Collaborate with existing national pharmacovigilance centres

in the Region, for the exchange of information and possible technical cooperation.

• Participate in the development process of WHO Guidelines on safety monitoring and pharmacovigilance of herbal medicines.

• Organize national workshop at the community level, for exchange of information and to explore possible options/criteria in establishing a national system for safety monitoring of herbal medicines

• Finalize the draft WHO guideline on safety monitoring and pharmacovigilance of herbal medicines.

• Organize training workshops for national capacity building on safety monitoring of herbal medicines.

Regional Meeting on MTR (2003)Recommendations

RATIONAL USE• Establish programs for provision of information, both to providers and

consumers, on the proper use of herbal medicines and other Traditional Medicine (TM)/Complementary and Alternative Medicine (CAM) products and therapies, based on the WHO guidelines for consumers on proper use of TM/CAM.

• Develop information materials/tool for consumers on proper use of TM/CAM.

• Finalize the draft WHO guideline for consumers on proper use of TM/CAM.

• Organize training workshop for Member States on proper use of TM/CAM by consumers.

• Promote education and training on herbal medicines for health care services providers.

• Incorporate subjects relating to herbal medicines, in the curricula of the Health care professionals and Health workers, in order them to acquire adequate technical knowledge and skills on herbal medicines and to promote its proper use.

• Provide technical guidance on basic education and training for providers of herbal medicines and for others of selected TM/CAM.

Background (Americas) IV

I meeting of the PANDRH WG on Medicinal Plants

I meeting of the PANDRH WG on Medicinal Plants

(Feb 2003)

• Mission• Objectives

Background (Global)

• International Regulatory Cooperation for Herbal medicines (IRCH)

• Established in Dec 2005 – 1rst meeting. Dec 2005. Canada– 2nd Meeting. Oct 2006. China

• Mission: IRCH is a network to protect and promote public health and safety through improved regulation for HM.

• PANDRH invited to be part of IRCH.– A member will be selected: regulator, member of the

WG, English. Proposal must be approved by the SC.

Background (Global)WHO DOCUMENTS

• WHO/TRM Legal Status

• WHO/TRM Consumers Guideline

• WHO/TRM Research & Evaluation

• WHO/TRM Regulatory Situation of Herbal Medicines

• Good Agricultural Practices