The World Health Organisation (WHO) and the African Medicines Agency (AMA) have launched a landmark framework to strengthen regulatory systems and improve access to safe, effective, and quality-assured health products across Africa. This new collaboration marks a major step toward a harmonized and resilient regulatory ecosystem, as well as accelerated access to health products across the continent.
Signed on the sidelines of the Seventy-ninth World Health Assembly (WHA79) during a high-level ministerial side event, the agreement establishes a structured partnership to advance regulatory harmonization, convergence, and reliance across Africa. It also supports the operationalization of AMA as a key continental institution.
Strengthening Regulatory Systems
Speaking during the signing ceremony, WHO Assistant Director-General for Health Systems, Access and Data, Yukiko Nakatani, said strong regulatory systems are central to resilient health systems and fundamental to health sovereignty, health security, and equitable access to safe and quality-assured health products. Nakatani noted that the launch of the framework agreement marks a decisive step toward building a more unified, efficient, and resilient regulatory ecosystem in Africa that would benefit not only the continent but the wider world.
According to WHO, WHA79 comes at a critical time as universal health coverage, pandemic preparedness, and equitable access to quality health products increasingly depend on strong regulatory systems. Across Africa, fragmented regulatory frameworks, limited local manufacturing, weak market surveillance, and complex supply chains continue to delay access, while substandard and falsified medical products remain a major challenge.
Protecting Lives and Building Trust
Director-General of AMA, Delese Darko, emphasized that strong regulation is ultimately about protecting lives and building public trust. He added that every African should have confidence that the medicines, vaccines, and other health products they receive meet the highest standards of quality, safety, and efficacy. He stated, "The African Medicines Agency is a historic opportunity to transform how medical products are regulated across the continent by strengthening cooperation, reducing fragmentation, and accelerating access to quality-assured health products for all Africans. This collaboration with WHO marks an important step toward turning that vision into reality."
The newly signed framework agreement builds on the renewed African Union–WHO Memorandum of Understanding signed in May 2025, reaffirming a longstanding strategic partnership. It provides the foundation for joint operational plans over the next three to five years, outlining priority areas of collaboration, timelines, and deliverables to support regulatory system strengthening at national, regional, and continental levels.
Impact on Health Security
WHO Regional Director for Africa, Mohamed Janabi, said the success of AMA would not be measured merely by the establishment of an institution, but by its impact through safer medicines, faster access, and stronger health security for Africans. He stressed that a strong and harmonized regulatory ecosystem is essential to advancing universal health coverage, strengthening confidence in health systems, and positioning Africa as a major actor in global health governance.
Established as a specialized agency of the African Union, AMA is mandated to strengthen regulatory capacity and improve access to quality-assured medical products across the continent. Its operationalization is expected to address longstanding challenges, including fragmented regulatory systems, limited market oversight, and the persistent threat of substandard and falsified medical products.
Key Areas of Collaboration
Under the agreement, WHO and AMA will collaborate to:
- Accelerate access to safe and effective health products
- Promote regulatory harmonization and reliance
- Strengthen safety surveillance and responses to falsified products
- Build regulatory capacity and workforce development across Africa
- Support innovation, local production, and preparedness during public health emergencies
A key objective is to streamline regulatory processes across Africa, reducing duplication and enabling faster approval of medical products. A more aligned system is expected to improve efficiency, lower costs, and create a more predictable investment environment for manufacturers and patients alike.
Political Support and Treaty Ratification
The high-level side event brought together Ministers of Health, African Union institutions, national regulatory authorities, and global partners to mobilize political support and reinforce commitments to regulatory reform, AMA treaty ratification, and sustained investment in regulatory system strengthening. AMA is also expected to serve as a model for regional regulatory cooperation by demonstrating how strong national authorities and effective reliance mechanisms can improve access, strengthen manufacturing, and enhance global health security.
Both organizations urged Member States and partners to build on the momentum by advancing reforms, accelerating treaty ratification, and investing in a trusted and harmonized regulatory ecosystem for all Africans.
Pathogen Access and Benefit Sharing Annex
In a related development, the World Health Assembly resolved to continue drafting and negotiating the Pathogen Access and Benefit Sharing (PABS) Annex under the Intergovernmental Working Group (IGWG) on the WHO Pandemic Agreement. The IGWG, acting under Article 12 of the agreement, will continue prioritizing the work. The PABS Annex aims to establish a framework for ensuring a more equitable response to future pandemics.
Over the past year, WHO Member States have held extensive negotiations on the annex, and the outcome was presented at the World Health Assembly. Member States agreed to submit the outcome of negotiations for consideration at the Eightieth World Health Assembly in May 2027 or at a special session of the Assembly in 2026. Adoption of the PABS Annex is considered critical to opening the WHO Pandemic Agreement for signature. Negotiations on the annex are scheduled to resume during the seventh meeting of the IGWG from July 6 to 17, 2026.
Public Health Emergency Preparedness
In Committee A, delegates discussed preparedness for and response to public health emergencies, including implementation of the International Health Regulations (2005) and reports from the Independent Oversight and Advisory Committee for the WHO Health Emergencies Programme. Delegates also examined the health impact of the ongoing Middle East conflict, focusing on the protection of healthcare facilities and workers in conflict settings, and reviewed WHO’s work in health emergencies. The committee subsequently adopted a draft decision on the health emergency in Lebanon.
Lessons from COVID-19
On the margins of the World Health Assembly, global leaders convened for a strategic roundtable reflecting on lessons from COVID-19 and other crises, coinciding with the tenth anniversary of the WHO Health Emergencies Programme (WHE). Opening the session, WHE Executive Director, Chikwe Ihekweazu, said the programme’s evolution has been shaped by lessons from successive emergencies, particularly COVID-19. WHO Director-General, Tedros Adhanom Ghebreyesus, described the pandemic as the “ultimate stress test,” exposing weaknesses in preparedness, equity, and trust, while also accelerating innovation and global collaboration. Former WHE Executive Director, Mike Ryan, added that global health systems have historically evolved reactively after crises such as SARS, Ebola, and COVID-19, and must now adapt proactively to future threats.
Experts highlighted several areas requiring transformation. Prof. Johanna Hanefeld stressed the importance of epidemic intelligence supported by advanced analytics and artificial intelligence, alongside strong national systems and public trust.
