Nigeria Already Has NAFDAC. Why Then Has It Joined Africa's Medicines Agency as Its 34th Member?

NAFDAC registers medicines, inspects manufacturing facilities and monitors the products sold in Nigeria.

So when the country announced on October 30, 2026, that it had become the 34th African Union member state to ratify the treaty establishing the African Medicines Agency (AMA), it might seem unnecessary for a country with an established regulator to join another one.

Why has Nigeria taken this long to join the AMA since its establishment, and what does joining now mean for NAFDAC, local pharmaceutical companies and Nigerians who buy medicines?

What will the African Medicines Agency do?

A Nigerian pharmaceutical company hoping to sell its products in Ghana, Kenya or Rwanda may have to meet different registration requirements in each country. It may also face separate inspections and approval processes.

This takes time and increases the cost of doing business across the continent.

The same problem affects regulators. When unsafe medicines move between countries, authorities need to share information and work together to respond. But different systems and limited resources can make this difficult.

This is one of the reasons the African Union established the AMA.

The agency is expected to help countries share information, improve their regulatory systems and work towards more consistent standards for medicines and other medical products.

. A 2024 review published in the Journal of Pharmaceutical Policy and Practice examined 27 studies covering 7,592 medicine samples from African countries.

It found that 22.6 per cent of the samples tested were substandard or falsified. This does not represent every medicine sold across Africa, but it shows the problem found in the studies.

In May 2026, the World Health Organisation (WHO) and AMA also signed an agreement to work together on medicine safety monitoring, regulatory processes, staff training and local pharmaceutical production.

Why is Nigeria joining now?

The African Union adopted the treaty establishing the AMA on February 11, 2019.

It came into force on November 5, 2021, after 15 countries ratified it. However, the agency only became operational in October 2025, with its headquarters in Kigali, Rwanda.

Several countries had completed ratification before Nigeria.

Rwanda, Ghana, Mali and Seychelles were among the early countries to join. Others, including Côte d'Ivoire, Ethiopia and Tanzania, followed in 2024, while Zambia, Botswana and Togo joined in 2025.

Nigeria's ratification came years after the treaty was adopted. In May 2026, a Devex report said the country was already in the final stages of the process.

Ratification can take time because it requires approvals within government and may involve several ministries and the legislature.

Nigeria's entry adds one of Africa's largest pharmaceutical markets and an established medicines regulator to the agency. Its participation could also strengthen the AMA's work as more countries come on board.

What could Nigeria gain, and when will Nigerians notice?

One area where Nigeria could benefit is pharmaceutical manufacturing.

The country still depends heavily on imported medicines.

Health Policy Watch had earlier flagged Nigeria as one of the big holdouts, and in May 2026, NAFDAC put historical dependence on imported medicines at about 70 per cent.

The agency has been working to encourage local production through measures such as its 5+5 policy, introduced in 2019 to move the manufacturing of selected medicines to Nigeria.

Selling locally made medicines in other African countries could give Nigerian manufacturers a larger market. However, meeting different regulatory requirements in each country can make expansion difficult.

If the AMA helps countries coordinate their approval processes and share the results of inspections, manufacturers may find it easier to enter other markets.

There could also be benefits for medicine safety. If regulators share information about unsafe or falsified products more quickly, other countries can investigate and take action sooner.

This could help prevent products flagged in one country from continuing to circulate elsewhere.

Better cooperation could help regulators monitor products more effectively and improve access to quality-assured medicines.

But joining the AMA will not automatically make medicines cheaper or eliminate fake drugs, it also does not mean that a medicine approved in Nigeria can immediately be sold across every African country.

While NAFDAC still remains responsible for regulating medicines in Nigeria, the AMA gives it a platform to work more closely with other African regulators on problems that extend beyond the country's borders.