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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

Gaps from the Perspective of NGOs/ Foundations/PDPs IoM Workshop: International Regulatory Harmonization Amid Globalization of Biomedical Research & Medical

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Page 1: Gaps from the Perspective of NGOs/ Foundations/PDPs IoM Workshop: International Regulatory Harmonization Amid Globalization of Biomedical Research & Medical

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

Page 2: Gaps from the Perspective of NGOs/ Foundations/PDPs IoM Workshop: International Regulatory Harmonization Amid Globalization of Biomedical Research & Medical

© 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

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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

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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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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

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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

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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)

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© 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)

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Thank you