WHO signs landmark regulatory cooperation agreement with African Medicines Agency at WHA79

SWITZERLAND—The World Health Organization (WHO) and the African Medicines Agency (AMA) have signed a Framework Agreement for Collaboration in Geneva, marking a major step towards strengthening regulatory systems across Africa.

Launched during a high-level side event at the Seventy-ninth World Health Assembly (WHA79), the agreement sets out a structured partnership to advance regulatory harmonization, convergence, and reliance among member states while supporting AMA’s operational rollout.

It also aligns with ongoing WHO discussions during WHA79 week, where global health leaders have recently emphasized the need for stronger regulatory capacity to improve access to quality-assured medicines and vaccines across global regions today.

Strengthening Africa’s Regulatory Systems

Across Africa, fragmented regulatory frameworks, limited manufacturing capacity, weak market surveillance, and complex supply chains continue to delay access to essential health products.

In addition, substandard and falsified medicines remain a persistent public health challenge that undermines trust in health systems and increases patient risk.

Through the new framework, WHO and AMA will coordinate efforts to streamline approval processes, enhance post-market surveillance, and build regulatory workforce capacity.

The agreement further supports innovation and local production, especially as countries seek to improve preparedness for public health emergencies.

By reducing duplication across national authorities, the partnership aims to create a more predictable regulatory environment that encourages investment and accelerates patient access to safe products.

Leadership emphasizes trust, safety, and impact

Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data, said strong regulatory systems underpin health sovereignty, security, and equitable access to quality-assured products.

She added that the framework marks a decisive step toward a unified regulatory ecosystem that benefits Africa and contributes to global health resilience.

H.E. Dr Delese Mimi Darko, Director-General of AMA, emphasized that regulation is about protecting lives and building public trust.

She noted that every person should have confidence in the safety and quality of medicines and vaccines, and that AMA provides a historic opportunity to reduce fragmentation and improve cooperation across the continent.

Dr Mohamed Yakub Janabi, WHO Regional Director for Africa, stated that outcomes, including safer medicines, faster access, and stronger health security will measure the success of AMA.

He further highlighted that a harmonized regulatory ecosystem is essential for universal health coverage and for strengthening Africa’s role in global health governance.

Implementation roadmap and continental cooperation

The Framework Agreement builds on the African Union–WHO Memorandum of Understanding, renewed in May 2025, and reinforces long-term cooperation on regulatory strengthening.

It sets out joint operational plans for the next three to five years, focusing on harmonization, surveillance, workforce development, and emergency preparedness.

It also supports accelerating access to safe health products and advancing treaty ratification among member states.

The side event in Geneva convened health ministers, regulators, and partners to reinforce commitment to regulatory reform and sustained investment in health systems.