West African nations are moving toward harmonised biomanufacturing regulations through regional frameworks, experts said at the West Africa Bio-manufacturing Regulation and Market Access Conference in Accra. This approach aims to create a unified regulatory system that allows vaccines and biologics produced in one country to be accepted across the region without delays.
H.E. Dr. Delese Darko, Director-General of the African Medicines Agency, explained that West African countries are not starting from zero. Existing regional harmonisation models in medicines, agriculture, and biosafety provide a foundation for advanced biotechnology regulation. “West Africa has already demonstrated success in harmonising regulatory frameworks for medicines and vaccines. The challenge now is translating that success into biomanufacturing,” she said.
The Economic Community of West African States (ECOWAS) sets regional policy, while the West African Health Organization (WAHO) coordinates technical and regulatory work. Initiatives such as the West Africa Medicines Regulatory Harmonisation (WA-MRH) demonstrate how joint approvals and common standards can accelerate product access in multiple countries.
Experts highlighted the importance of technical alignment, including Good Manufacturing Practice (GMP), pharmacovigilance, cell and gene therapy standards, bioprocess validation, and laboratory quality control. Harmonisation also extends to biosafety, traditional medicine, and emerging biotechnologies.
H.E. Dr. Darko stressed that regional collaboration is essential for achieving Africa’s goal of producing 60% of its vaccines locally by 2040, noting that over 95% of vaccines are currently imported.
Conclusion:
Experts concluded that harmonised regulations, joint approvals, and national implementation of regional standards are critical to making West African biomanufacturing globally competitive. Political commitment, capacity building, and harmonised procurement systems were identified as key steps for success.