Wellcome Commits US $12.3 Million to Support Regulatory Harmonisation and AMA Operationalisation

Johannesburg, South Africa — 7 October 2024 — In a significant step towards enhancing the regulation of medical products across Africa, AUDA-NEPAD announced that Wellcome has granted US $12,301,075 to support the strengthening and harmonisation of regulatory systems and the operationalisation of the African Medicines Agency (AMA).

This substantial investment will support:

• Strengthening regulatory harmonisation across African countries
• Supporting the operationalisation of the African Medicines Agency (AMA)
• Building capacity of National Regulatory Authorities (NRAs)
• Enhancing regulatory systems for medical products
• Facilitating mutual recognition agreements among African countries
• Supporting the African Medicines Regulatory Harmonisation (AMRH) program

The funding from Wellcome represents a major commitment to improving access to quality, safe, and efficacious medicines across the African continent. It will enable AUDA-NEPAD to accelerate its work in harmonising regulatory standards and supporting the establishment of the AMA as a fully operational continental regulatory body.

This investment aligns with the African Union's Agenda 2063 and supports the continent's pharmaceutical manufacturing capacity through the Pharmaceutical Manufacturing Plan for Africa (PMPA). The partnership between AUDA-NEPAD and Wellcome demonstrates the global commitment to strengthening Africa's regulatory infrastructure and ensuring that African populations have access to quality-assured medical products.

The AMRH program, led by AUDA-NEPAD, has been instrumental in advancing regulatory harmonisation across the continent, and this funding will enable the program to expand its reach and impact.