WHO and African Medicines Agency Launch Partnership to Strengthen Medicine Regulation

WHO officials stressed that effective medicine regulation is essential for building resilient healthcare systems and protecting public health.

The World Health Organization (WHO) and the African Medicines Agency (AMA) have officially launched a new Framework Agreement for Collaboration aimed at transforming medicine regulation and improving access to safe, effective, and quality-assured health products across Africa.

The agreement was signed during the Seventy-ninth World Health Assembly (WHA79) at a high-level ministerial side event, marking a major step toward creating a stronger and more unified regulatory system for medicines, vaccines, and other medical products throughout the continent.

Health officials say the partnership comes at a critical time as African countries continue working to strengthen healthcare systems, improve pandemic preparedness, and expand access to affordable and reliable medical products.

The collaboration between WHO and AMA is expected to help tackle some of the biggest healthcare challenges facing Africa, including fragmented regulatory systems, weak market surveillance, limited pharmaceutical manufacturing capacity, and the growing circulation of substandard and falsified medicines.

WHO officials stressed that effective medicine regulation is essential for building resilient healthcare systems and protecting public health.

Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data, described the agreement as a major milestone in strengthening health security and regulatory cooperation across Africa.

"Strong regulatory systems are fundamental to health sovereignty, health security, and equitable access to safe and quality-assured medical products," Nakatani said.

She noted that the partnership will support the creation of a more efficient and resilient regulatory ecosystem capable of benefiting not only African countries but also global health systems more broadly.

The African Medicines Agency, established as a specialised agency of the African Union, was created to strengthen regulatory oversight and improve access to quality health products across the continent.

Its operationalisation is widely viewed as a historic opportunity to address long-standing regulatory challenges that have slowed access to essential medicines in many African countries.

AMA Director-General Dr Delese Mimi Darko said strong regulation is ultimately about saving lives and building public confidence in healthcare systems.

"Every African should be able to trust that the medicines and vaccines they receive meet the highest standards of safety, quality, and effectiveness," Darko said.

She added that AMA has the potential to fundamentally transform how medical products are regulated in Africa by improving cooperation between countries, reducing duplication, and accelerating access to life-saving treatments.

The newly signed framework builds upon the renewed African Union–WHO Memorandum of Understanding signed in May 2025 and establishes a roadmap for joint cooperation over the next three to five years.

The agreement outlines key priority areas for collaboration, including:

• Accelerating access to safe and effective health products

• Promoting regulatory harmonization and cooperation

• Strengthening surveillance against substandard and falsified medicines

• Expanding regulatory workforce capacity across Africa

• Supporting local pharmaceutical production and innovation

• Improving preparedness during public health emergencies

One of the central goals of the partnership is to streamline regulatory approval processes across African countries.

Currently, many pharmaceutical companies must navigate multiple separate approval systems across the continent, creating delays, increasing costs, and limiting access to essential medicines.

A more harmonized regulatory system is expected to reduce duplication, improve efficiency, and create a more predictable environment for both local and international manufacturers.

Experts say this could also encourage greater investment in African pharmaceutical manufacturing and healthcare innovation.

WHO Regional Director for Africa Dr Mohamed Yakub Janabi said the success of AMA will ultimately be measured by real-world improvements in public health outcomes.

"The true measure of success will be safer medicines, faster access to treatment, and stronger health security for African populations," Janabi said.

He emphasised that a strong and harmonized regulatory ecosystem is essential for achieving universal health coverage and strengthening confidence in African health systems.

The agreement was announced during a high-level gathering that brought together Ministers of Health, African Union institutions, national regulatory agencies, and international partners to reinforce support for regulatory reform and AMA Treaty ratification.

International health experts believe the African Medicines Agency could eventually become a global model for regional regulatory cooperation, similar to how the European Medicines Agency supports coordinated medicine regulation across Europe.

By strengthening regulatory reliance and cooperation between countries, African nations could improve medicine access, strengthen pharmaceutical manufacturing, and enhance preparedness for future pandemics and health emergencies.

WHO and AMA have urged African governments and international partners to continue supporting regulatory reforms, accelerate treaty ratification processes, and invest in building trusted and efficient healthcare regulatory systems.

The partnership reflects growing recognition that strong medicine regulation is not only a healthcare issue but also a major component of economic development, public trust, and global health security.