Nigeria has deposited its instrument of ratification of the African Medicines Agency (AMA) Treaty, becoming the 34th African Union member state to complete the process and strengthening efforts to harmonise medicines regulation across the continent.
The development is expected to deepen cooperation among African drug regulators, improve oversight of medical products and support efforts to tackle substandard and falsified medicines.
The announcement was made by Ambassador A. Twum-Amoah, African Union Commissioner for Health, Humanitarian Affairs and Social Development, at the inaugural African Medicines Agency Week in Kigali, Rwanda, which ended on October 30.
The Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, who attended the event, described Nigeria’s participation as an important step towards strengthening public health protection and pharmaceutical development in Africa.
According to NAFDAC, Nigeria’s membership provides an opportunity to deepen collaboration with the AMA and other national and regional regulatory institutions through information sharing, scientific cooperation and regulatory capacity development.
The African Medicines Agency is a specialised institution of the African Union established to strengthen the capacity of national and regional regulatory authorities and improve access to safe, effective and quality-assured medical products.
Its treaty, adopted in February 2019, seeks to promote cooperation and harmonisation of medicines regulation, including the sharing of regulatory expertise and greater coordination among member states. It entered into force on November 5, 2021, after the deposit of the 15th instrument of ratification.
For Nigeria, participation comes as the country continues to address the circulation of substandard and falsified medicines, while seeking to expand local pharmaceutical manufacturing.
Adeyeye said the ratification reinforces Nigeria’s commitment to combating falsified medical products, promoting pharmaceutical innovation and supporting local manufacturing as part of efforts to strengthen health security and economic development.
She, however, stressed that the achievement must translate into practical action through sustained institutional cooperation, regulatory capacity development and effective implementation of the treaty.
The AMA’s work is also expected to support more coordinated regulatory processes across African countries. The World Health Organisation and the agency signed a framework agreement in May 2026 to strengthen regulatory harmonisation, improve safety monitoring and support access to quality-assured health products.
For pharmaceutical manufacturers, greater regulatory cooperation could help reduce duplicated regulatory processes and make it easier to navigate different African markets. However, this will depend on how the agency and national regulators implement the framework.
Nigeria’s ratification is therefore an important step towards continental regulatory cooperation, but it does not automatically mean that medicines approved by NAFDAC will receive automatic approval across other African countries.
Adeyeye said the ultimate measure of the agency’s success would be its ability to improve access to safe, effective, quality-assured and affordable medicines across Africa.
She described Nigeria’s participation as an investment in the continent’s health security, pharmaceutical sovereignty and sustainable development.
