1 |1 | advanced technical briefing seminar : quality assurance and safety of medicines: promoting...
TRANSCRIPT
1 |Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
Dr Samvel AzatyanManager, Medicines Regulatory Support ProgrammeQuality Assurance and Safety: MedicinesEssential Medicines and Health ProductsWorld Health OrganizationE-mail: [email protected]
Overview of medicines regulation:regulatory cooperation andharmonization in the focus
2 |Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
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 |Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
Government's role is crucialGovernment's role is crucial
Governments are obliged to intervene in the activities of the private sector due to public health and safety concerns;
Medical products include: medicines, blood products, vaccines and other biological and biotechnological products, diagnostics, medical devices, traditional medicines and other health-care products;
Regulation of medical products in the countries is performed through National Regulatory Authorities
(NRAs)
4 |Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
The overall objective of a National Regulatory Authorities (NRAs) for medical products is to ensure that all medical products (medicines, vaccines, blood products and other biologicals) and medical devices that are used in a country are of assured quality, safety and efficacy and are accompanied by appropriate information to promote their rational use.
NRAs need to be competent, independent, with strong political backing and have clear authority to enforce established regulations.
Role of a National Regulatory AuthoritiesRole of a National Regulatory Authorities
5 |Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
The role of a National Regulatory AuthorityThe role of a National Regulatory Authority
Medical products regulatory authority means a network (institution) that administers the full spectrum of 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 |Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
Medicines regulation should: Have patient in the focus; Be evidence and science based; Be risk based; 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 of the
country.
Main principles of medicines regulation – although, not always observed..
Main principles of medicines regulation – although, not always observed..
7 |Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
Main principles of medicines regulation – although, not always observed..
Main principles of medicines regulation – although, not always observed..
…But also keep in mind, that:
Regulations must be attuned not to the wishes, but 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;
… Attempts to apply more sophisticated requirements may have (at least, in short term) serious public health implications.
8 |Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
Differences in regulatory capacity globallyDifferences in regulatory capacity globally
194 WHO Member States:
20% 50%
30% Developed
Variable
Limited
The reality is that due to chronic shortages of human, technical, financial and other resources many regulatory authorities don't have the full capacity to perform all core regulatory functions
9 |Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
Assessments of medicines regulatory systems in 26 sub-Saharan African countries
Assessments of medicines regulatory systems in 26 sub-Saharan African countries
Guidelines and assessment procedures are not up to international standards and are often of an administrative rather than technical nature;
Wide-ranging exemption clauses exist which are not justified by a risk assessment, for example for public sector imports or donations;
Inadequate resources severely limited technical assessment of dossiers;
In spite of resource constraints only few countries relied on decisions made by other regulators (such as stringent NMRAs or by the WHO Prequalification Programme);
Regulatory decisions by other competent authorities were not widely considered.
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Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
Challenges and problems posed by a lack of appropriate regulation
Challenges and problems posed by a lack of appropriate regulation
In many low- and middle income countries most essential medicines are not readily available and accessible due to insufficient regulatory capacity and a lack of harmonized technical requirements for medicines registration
Poor uptake of new and existing health solutions costs millions of lives across low-income countries
A lack of essential medicines contributes to disparities in health and life-expectancy between low- and middle income and high-income countries
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Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
WHO approaches to cope with increasing demands and limited resources
WHO approaches to cope with increasing demands and limited resources
Avoid doing things that do not give added value;
Concentrate on things that do give added value;
Pragmatically and focus on priority issues, which are most relevant for public health (risk-benefit approach);
Increase effectiveness of internal operations;
Co-operate with partners in order to eliminate duplicated activities;
Share your work with others – do what you can do well and let others do what they could do better
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Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
Prioritization of the regulatory activitiesPrioritization of the regulatory activities
Many NMRAs with limited resources may limit their scope of activities to performance of those "core" regulatory functions, which could potentially bring maximum added value to the public health;
Other regulatory functions could be more and more shared with the colleagues in other NMRAs (especially in the frameworks of existing RECs) and relying on the opinions made and decisions taken by other regulators;
This will allow WHO and other partners to prioritize the support efforts and to introduce a system for accreditation (or prequalification) of NMRAs for performance of specific regulatory functions, in accordance with specific international standards.
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Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
More specific "innovative" (or heretic..) approach
More specific "innovative" (or heretic..) approach
Introduction of the concept of "levelling" for the pharmaceutical products (essential medicines), according to the "quality-related risk", into:
─ Low risk products
─ Medium risk products
─ High risk products
This will create incentives and motivation for the development, in case if NMRA wishes to "jump" a level up, e.g., from regulation of low risk products to medium risk products.
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Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
Developing evidence - assessments of regulatory systems worldwide (more than 50 NMRAs assessed in all 6 regions);
Providing direct technical support (capacity building, tools and guidance) to regions and countries;
Stimulating / initiating collaboration between regulators from various countries on various regulatory activities;
Promoting and facilitating communication among national/regional regulatory systems using ICDRA, specific network meetings (e.g. WHO Annual Pharmacovigilance Centres meetings, and International Regulatory Cooperation for Herbal Medicines (IRCH);
Promoting regulatory collaboration and harmonization.
What WHO/MRS is doingto support regulators
What WHO/MRS is doingto support regulators
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Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
Collaboration with other Programmes and Units within EMP and outside
Collaboration with other Programmes and Units within EMP and outside
HSS/EMPHSS/HDS
QSM (PQ, Safety)QSM (Quality Assurance)QSM (Blood products)MAR (GGM)TRM (IRCH)
WHO Medicines Regulatory Support Programme
Disease-oriented programmes
HTM/GMP(Global Malaria Programme)Other Programmes
FCH/IVB
QSS(Regulatory pathways)
National Medicines Regulatory Authorities
WHO Regional Offices WHO Country Offices
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Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
Sharing regulatory information is a key to faster access to medicines
Sharing regulatory information is a key to faster access to medicines
WHO 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.
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Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
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
Sharing of expertise vs. recognition of decision
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Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
New regulatory approachesNew 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.
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Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
What we What we dodo mean under harmonization mean under harmonizationWhat 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 medicines registration;
Can prepare the ground for mutual recognition and/or centralized registration in the longer-term future.
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Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
What we What we definitely don't definitely don't mean under mean under harmonizationharmonization
What we What we definitely don't definitely don't mean under mean under harmonizationharmonization
Harmonization doesn't mean a loss of national sovereignty / autonomy (and certainly not in the early stages);
In all cases the registration decision itself remains firmly in the hands of sovereign nations;
Collaborative mechanisms, such as joint assessments or inspections, does not imply collaborative decision-making!
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Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
The primary aim of harmonizing technical requirements and processes for medicines registration is to improve public health, by increasing timely access to safe and effective medicines of good quality for the treatment of priority diseases.
Access will be increased by reducing the time it takes for essential medicines to be registered in‐country, without compromising quality and, potentially, the time taken for essential therapies to reach patients in need.
This will require capacity building to ensure transparent, efficient and competent regulatory activities, including assessment of registration dossiers and related inspections, that are able to assure the quality, safety and efficacy of registered medicines.
Expectations from harmonizationExpectations from harmonization
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Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
Potential public health gains from harmonization
Potential public health gains from harmonization
Less risk of being harmed by medicines 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 there will be no waste on substandard and of poor-quality medicines.
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Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
Potential gains have to be balanced with… potential losses
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.
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Advanced Technical Briefing Seminar : Quality Assurance and Safety of Medicines: Promoting Global Collaboration. 25–29 June 2012, WHO Headquarters, Geneva
ConclusionsConclusions
Medicines regulation is not anymore a "single-player" activity;
Prioritization of regulatory activities, work sharing and collaboration can help reduce workload and improve public health by improving 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.