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Overview on Medicines Regulation: regulatory cooperation and harmonization in the focus. Dr Samvel Azatyan Manager, Medicines Regulatory Support Programme Quality Assurance and Safety: Medicines Essential Medicines and Pharmaceutical Policies World Health Organization E-mail: [email protected]. - PowerPoint PPT Presentation
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1 |Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
Dr Samvel AzatyanManager, Medicines Regulatory Support ProgrammeQuality Assurance and Safety: MedicinesEssential Medicines and Pharmaceutical PoliciesWorld Health OrganizationE-mail: [email protected]
Overview on Medicines Regulation: regulatory cooperation andharmonization in the focus
2 |Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
Why regulation of medicines is needed?
What is special with medicines, compared to other goods / commodities?
As a rule, patients are not able to make independent judgement about of the QUALITY, SAFETY and EFFICACY;─ Even health professionals have difficulties, unless they are
specially trained;
Medicines regulation is the totality of all measures - legal, administrative and technical - which governments undertake to ensure the quality, efficacy and safety of medicines, as well as the relevance and accuracy of the product information.
3 |Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
irrational consumption and prescription; quality of medicines is not assured - substandard,
counterfeit, harmful, useless medicines on the market.
Consequences of under-regulation dueto the weak regulatory capacity
Consequences of over- or improper regulation shortage of needed medicines or delayed access; increased costs of medicines due to the cost of
regulatory system.
Why regulation of medicines is needed?
4 |Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
Rationale for Government's role
Governments are obliged to intervene in the activities of the pharmaceutical sector due to public health and safety concerns;
In this context, medicines regulation is a public policy that restricts private sector activities in order to attain social goals identified by the State;
Medicines regulation in the countries is performed through National Medicines Regulatory Authorities
(NMRAs)
5 |Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
Medicines regulatory authority
In a broad sense medicines regulatory authority means a network (institution) that administers the full spectrum of drug regulatory activities, including at least the following functions:
Marketing authorization for new products and variation of existing authorizations;
GMP, GCP, GLP inspections; Licensing and post-license control of manufacturers, wholesalers and
other distribution channels; Quality control laboratory testing; Adverse drug reaction monitoring; Provision of drug information and promotion of rational drug use; Enforcement operations; Monitoring of Drug Utilization, etc.
6 |Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
Medicines regulation should: Have patient in the focus; Be evidence based; Be risk oriented; Bring added value; Respect interests of stakeholders and real possibilities; Be transparent but respect confidentiality; Be effective and flexible; Be part of broader overall pharmaceutical policy.
Main principles of medicines regulation
7 |Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
Main principles of medicines regulation
…But also keep in mind, that:
Regulations must be attuned to available resources (technical, human, financial, etc.);
Due to the complexity and resource constrains, the requirements developed and successfully implemented in one country may not be equally successful in another country;
The application of more sophisticated requirements may have (at least, in short term) serious public health implications.
8 |Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
Differences in regulatory capacity globally
193 WHO Member States:
20% 50%
30% DevelopedVariableLimited
For different reasons, many regulatory authorities do not have the full capacity to perform all regulatory functions.
9 |Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
Differences in regulatory capacity in African Region
46 WHO Member States:
4%
33%
24%
39% DevelopedModerateBasicLimited
Source: WHO/AFRO/EDP/04.5: Availability of Drug Regulatory and Quality Assurance Elements in Member States of the WHO African Region, 2004, Brazzaville.
10 |
Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
Not all regulatory functions are performed due to chronic shortages of human, technical and financial resources;
Different institutional arrangements exist for the regulation of medicines:
Weak regulatory frameworks and lack of enforcement can lead to various bottlenecks limiting access to essential medicines.
Regulators are perceived as an additional "road-block" to access to new therapies..;
Critical issues in regulation of medicines
11 |
Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
Strategies to cope with increasing demands
Avoid doing things that do not give added value; Concentrate on things that do give added value; Be pragmatic and focus on priority issues, most relevant for
public health (risk-benefit approach); Increased effectiveness of internal operations
─ Quality systems, international benchmarking; Co-operation with partners in order to increase regulatory
capacity by elimination of duplicated activities─ Facilitated by comparable standards and administrative
requirements.
12 |
Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
Developing evidence - assessments of regulatory systems worldwide (around 50 NMRAs assessed in all 6 regions);
Providing direct technical support (capacity building, tools and guidance) to regions and countries (with PQ and IVB);
Stimulating / initiating collaboration between regulators from various countries on various regulatory activities (from "North → South" to "South ↔ South");
Promoting harmonization.
WHO approaches for regulatory support
13 |
Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
Collaboration of MRS Programme with other Programmes and Units within EMP and outside
HSS/EMPQSM (PQ, Safety)QSM (Quality Assurance)QSM (Blood products)MAR (GGM)
Medicines Regulatory Support
Disease-oriented programmes
HTM/GMP(Global Malaria Programme)Other Programmes
FCH/IVBQSS(Regulatory pathways)
National Medicines Regulatory Authorities
WHO Regional Offices WHO Country Offices
14 |
Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
Faster access to medicines throughsharing of regulatory information
MRS is working with regulators to find out how best to build confidence in regulatory decisions taken by other regulators, including:
─ how to facilitate exchange of consolidated information about assessments and inspections;
─ without challenging their sovereignty.
"You kids share your food and stop being shellfish!"
15 |
Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
Acceptance of expertise is not equal to acceptance of decision:
Acceptance of expertise– is sovereign and complex regulatory decision of NRA based on
scientific arguments and confidence; – may be applied case to case;– is followed by formal independent decision according to national
legislation and mandate of national MRA; Acceptance of decision
– is a formal legal act, frequently requiring international treaties;– may modify liabilities of involved parties and requires legal
specification of acceptance and non-acceptance.
Sharing of expertise vs. recognition of decision
16 |
Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
New regulatory approaches
Smaller or less resourced regulatory authorities more and more starting to rely on the approvals or opinions issued by the well-resourced regulatory authorities
Examples of this type of initiatives include, but are not limited to:
WHO PQP - HIV/AIDS, TB, malaria, RH, paediatric therapy; US PEPFAR - HIV/AIDS; EU Article 58 – assessment of products for use outside the
European Union territory; Canada's Access to Medicines Regime – assessment of
products according to WHO Model List of Essential Medicines; Other – orphan medicines, paediatric medicines.
17 |
Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
Regulatory harmonization
In a broad sense harmonization means harmonization of technical requirements for medicines regulation, i.e., legislations, guidelines, procedures, etc.
These requirements relate to the quality, safety and efficacy of the medicinal products;
These requirements differ in complexity, from one type of marketing authorization application to another.
18 |
Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
What we What we dodo mean under Harmonization? mean under Harmonization?
True harmonization goes further than just development of common documentation;
It requires effective communication and collaboration aimed at building capacity and trust (e.g., information sharing, recognition and joint working);
In combination, these activities can lead to similar or collaborative approaches to drug registration;
Paving the way for mutual recognition and/or centralized registration (if desired) in the longer-term future.
19 |
Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
What we What we do not do not mean under Harmonization?mean under Harmonization?
Harmonization doesn't mean a loss of national sovereignty / autonomy (and certainly not in the early stages)
Common documentation stipulates the requirements for registration;
Better communication enables countries to chose which information they will use;
Collaborative mechanisms, such as joint assessments or inspections, does not imply collaborative decision-making!
In all cases the registration decision itself stays firmly in the hands of sovereign nations
20 |
Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
Potential public health gains from harmonization
Less risk of being harmed by medicines (safety risks combined with no treatment effect risks) as gradual improvement of quality, safety and efficacy of products on the markets is expected;
More rapid access to needed medicines (high priority essential medicines, new medicines…);
Better value for money (both for out of pocket and public funds), as no waste on substandard and of poor-quality medicines;
Increasing trust in generic medicines (also better value for money).
21 |
Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
But… potential gains have to be balanced with… potential losses
Increased price level of medicines (quality has its price);
Reduced access – not all medicines on the market may meet new harmonized standards;
Increasing price for medicines regulation (harmonization has its price too);
Local industry may not always win;
Wholesale and retail businesses may loose many of the products that were bestsellers for them.
22 |
Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
Potential scope for harmonization in Africa
Harmonization of technical requirements– Generic drugs vs NCEs – move from generics to NCEs– Priorities (CTD, modules for generics, GMP), timeframes and
working methods for creation of guidelines to be determined;
Implementation of harmonized technical requirements;
Establishing for priority products a special pathway – one set of assessments/inspections – access to all markets
– Either via "centralized procedure" (one application, one process and one result for all) or "mutual recognition" (same application for all or some, one MRA does the job and others recognize without duplication).
23 |
Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
Regulatory harmonization in Africa
Africa – a continent of huge diversity and complex unity, with numerous Regional Economic Communities (REC);
… overlaps and politically complicated environment.
24 |
Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
African Medicines Registration Harmonization Initiative (AMRHI)
Process started with the informal consultations in ICDRA Meeting, September 2008, Bern, Switzerland;
In response to the growing recognition of the potential benefits of harmonizing medicines registration in Africa, a WHO concept paper was developed to describe a proposed approach to supporting drug registration harmonization within and across African regional groupings.
WHO Drug Information, Volume 22, Number 3, 2008
25 |
Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
African Medicines Registration Harmonization Initiative (AMRHI)
Further discussions and orientation in the meeting in Johannesburg, South Africa, 24-26 February 2009, organized jointly by BMGF, NEPAD, William J. Clinton Foundation and the WHO.
The purpose of the meeting was: to explore the possibilities of supporting medicine registration
harmonization, as an initial first step to broader regulatory harmonization within African Regional Economic Communities (RECs) and organizations, and
to initiate a strategic approach to develop project proposals for mobilizing the necessary financial and technical resources to support RECs undertaking medicine registration harmonization.
26 |
Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
African Medicines Registration Harmonization Initiative (AMRHI)
Donor partners, NEPAD and WHO confirmed their interest in supporting the RECs, including necessary actions to support national implementation, strengthen national regulatory agencies and promote inter-REC and continental exchange of information, coordination and technical consistency.
Their strategic approach was to invite summary project proposals from committed RECs and seek financial and technical support for the most sound and promising proposals among them.
27 |
Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
African Medicines Registration Harmonization Initiative (AMRHI)
next steps for further implementation of the project: By 31st May 2009 RECs were invited to submit to WHO and NEPAD a
summary project proposal in support of regional medicine registration harmonization. A draft format and a suggested scope and outline are available. NEPAD and WHO are willing to give limited technical support to the development of such regional proposals.
April - May 2009: Submission of summary project proposals; June 2009: Review of proposals and feedback to RECs; July - October 2009: Selected RECs to submit their full project proposals
to NEPAD & WHO; November-December 2009: Review of full project proposals by Project
consortium and submission to interested Donors; January - June 2010: Expected start of the implementation of first
approved projects. …..
28 |
Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
Conclusions
Sharing of information, collaboration and harmonization can help reduce workload and improve overall regulatory performance.
It can help to direct the expert knowledge and resources to performance of the functions that can improve public health and facilitate access to essential medicines;
Formation of effective networks between regulatory authorities nationally and internationally may facilitate sharing of scarce resources and eliminate duplicating of activities;
Harmonization may contribute in building regulatory capacity and trust, which is an important achievement in its own right.
29 |
Technical Briefing Seminar, 1 - 5 November 2010WHO Headquarters, Geneva, Switzerland
Thank you!
www.who.int/medicines
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