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Gaps from the Perspective of NGOs/ Foundations/PDPs

Explore gaps in biomedical research and product development regulation, barriers, recent approaches, and the path forward for NGOs and foundations.Vincent Ahonkhai, MD, FAAP, shares insights from the IoM Workshop on International Regulatory Harmonization.

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Gaps from the Perspective of NGOs/ Foundations/PDPs

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  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Barriers to closing the key gaps

  7. 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)

  8. 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)

  9. Thank you

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