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Gaps from the Perspective of NGOs/ Foundations/PDPs. Vincent Ahonkhai, MD, FAAP. IoM Workshop: International Regulatory Harmonization Amid Globalization of Biomedical Research & Medical Product Development Washington, DC February 13-14, 2013. Overview of topics for this presentation.
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Gaps from the Perspective of NGOs/ Foundations/PDPs Vincent Ahonkhai, MD, FAAP IoM Workshop: International Regulatory Harmonization Amid Globalization of Biomedical Research & Medical Product Development Washington, DC February 13-14, 2013
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
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
Diagnostics and medical devices is the top-priority product class for better harmonization • Priority ranking for product classes from a global health perspective: • Diagnostics and medical devices • No international standards • Vector control products • WHO Pesticide Evaluation Scheme has become central process • Drugs and vaccines • More work to do, but area where there has been the most effort 1 2 3
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
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)
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)