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24

MAR

Regulatory Harmonization & Localization Twin Pillars for Building Resilient Health Product Supply Chains

16:00 – 17:30 HRS. (IST)

Context

Africa has made significant progress in transitioning from fragmented national regulatory systems toward continental harmonization through AMRH initiatives and operationalization of the African Medicines Agency (AMA). Technical collaboration, including EMA support in the continental product listing pilot, has strengthened regulatory alignment and assessment methodologies. However, harmonization alone is insufficient for supply chain resilience. Localization through manufacturing expansion, technology transfer, and industrial policy reduces dependency, enhances emergency responsiveness, and retains economic value within the continent. Governments are increasingly pairing harmonized regulations with incentives and pooled procurement mechanisms to create predictable, investment-friendly ecosystems. This session examines how regulatory convergence and localization together advance self-reliance and supply chain resilience.

Objective

Highlight Africa’s progress in regulatory harmonization and continental listing.

Examine lessons from global regulatory collaboration models.

Analyze the role of localization and technology transfer in resilience.

Explore how harmonization and localization jointly stabilize supply chains.

Identify implications for LMICs pursuing regulatory and manufacturing reforms.

Mr. Girish Bommakanti (Moderator)

Mr. Girish Bommakanti (Moderator)

Global Director - Operations and Strategic Growth, ACCESS Health International

Dr. Alex Juma Ismail (Virtual)

Dr. Alex Juma Ismail (Virtual)

Program Officer - African Medicines Regulatory Harmonization, African Union Development Agency

Dr. Emily Kaine (Session Keynote)

Dr. Emily Kaine (Session Keynote)

Senior Vice President - Global Health & Manufacturing Services, United States Pharmacopeia

Mr. Maulik Chokshi

Mr. Maulik Chokshi

Global Director - Health Systems Research and Policy, ACCESS Health International

Dr. Rajiv Chhibber

Dr. Rajiv Chhibber

Vice President, External Affairs (Policy, Govt Relations & Outreach), Sahajanand Medical Technologies