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Gaps from the Perspective of NGOs/ Foundations/PDPs
IoM Workshop: International Regulatory Harmonization Amid Globalization of Biomedical Research & Medical Product Development
Washington, DC
February 13-14, 2013
Vincent Ahonkhai, MD, FAAP
© 2013 Bill & Melinda Gates Foundation |
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Overview of topics for this presentation
Top priority areas for harmonization
Key gaps in the current systems
Barriers to closing those gaps
Recent approaches to overcoming the barriers and addressing the gaps
Thoughts on the path forward
© 2013 Bill & Melinda Gates Foundation |
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The perspective of creating access and ensuring quality for the public market
Product development Registration Post-registration
Initial ("home-country") registration
WHO prequalification
Country registrations
© 2013 Bill & Melinda Gates Foundation |
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Diagnostics and medical devices is the top-priority product class for better harmonization
Priority ranking for product classes from a global health perspective:
1. Diagnostics and medical devices• No international standards
2. Vector control products• WHO Pesticide Evaluation Scheme has become central process
3. Drugs and vaccines• More work to do, but area where there has been the most effort
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© 2013 Bill & Melinda Gates Foundation |
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Key gaps in the global health regulatory landscape
Product development Registration Post-registration
Timely and effective ethical and regulatory approval for trials
Infrastructure and expertise to support and enforce GLP and GCP
3-step process of initial registration, WHO prequalification, and country registrations
Consistent and appropriate standards for registration submission
Communication and transparency to reduce duplication of efforts
Infrastructure to detect and report safety and effectiveness data
Technical expertise to interpret and act on safety and effectiveness data
© 2013 Bill & Melinda Gates Foundation |
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Barriers to closing the key gaps
Diversity of countries
The communicable disease burden and family health needs of low- and middle-income countries (LMIC) are distributed across 100+ countries around the world
Wide range of standards, activities, capabilities, and aspirations across those countries
Regulator resources
Lack of sufficient and sustained financing for critical activitiesDifficulty attracting, developing, and retaining staff with
technical expertise in a competitive market for limited talent
Trust and transparency
Limited mechanisms for LMIC regulators to confidently rely on activities and assessments (like GMP inspections) of other regulators
Sponsor resources
Lack of regulatory experience and capacity at global health PDPs compared to commercial developers
Prioritization of commercial interests for product development and launch over public market access
© 2013 Bill & Melinda Gates Foundation |
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Recent approaches to overcoming the barriers and addressing the gaps
Product development Registration Post-registration
African Vaccine Regulatory Forum (AVAREF)
European & Developing Countries Clinical Trials Partnership (EDCTP)
Critical Path to TB Drug Regimens (CPTR)
WHO Prequalification programs (PQ)
African Medicines Regulatory Harmonization (AMRH)
WHO Global Vaccine Safety Blueprint
Safety Surveillance Working Group (SSWG)
WHO Pesticide Evaluation Scheme (WHOPES)
© 2013 Bill & Melinda Gates Foundation |
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Thoughts on the path forward
We need a better understanding of the landscape of issues The global regulatory system is too complex to make decisions based only
on intuition or anecdote
Comprehensive stakeholder engagement is critical for informed decision-making and for successful implementation of change
There are many issues we could address: we must deliberately assess where we can have the most impact, and deprioritize other areas
We have had successes, and we need to continue to support and expand those going forward
E.g., the development, introduction, and safety surveillance of MenAfriVac (meningitis A vaccine for the African meningitis belt)
© 2013 Bill & Melinda Gates Foundation |
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Thank you