Getting a new medicine approved across Africa used to mean going through 54 separate national approval processes, one country at a time. The African Medicines Regulatory Harmonization Initiative changed that by getting regulators to review medicines together, and laid the groundwork for a continental medicines agency.

The dilemma

For most of the period after independence, a pharmaceutical company that wanted to sell a new medicine across Africa had to apply for approval in each country separately. That meant 54 different applications, 54 different reviews, and 54 different timelines. Some countries had well-staffed medicines regulators with the scientific capacity to assess complex applications. Others had only a handful of staff and could not keep up. The result was that companies spent years filing the same paperwork in country after country. Patients waited longer than they should have for medicines that had already been approved elsewhere on the continent. And smaller regulators were overwhelmed by workloads they could not handle. The continent was effectively paying twice, once in time and once in scarce expert capacity, for the same scientific assessment.

The regulatory gap

What Africa needed was a way for its medicines regulators to share the work. That meant joint reviews of new medicine applications, agreements to recognise each other's approvals, and a continental body that could coordinate across countries without overriding national governments. No single country had the authority to set this up. It had to be built across the continent.

The approach

In 2012, the African Union Development Agency, known as AUDA-NEPAD, launched the African Medicines Regulatory Harmonization Initiative, or AMRH. It worked in partnership with the World Health Organization and the African Union's Regional Economic Communities. The initiative set up Regional Centres of Regulatory Excellence, where regulators from neighbouring countries could review new medicines together. It also worked toward a continental institution, the African Medicines Agency, whose founding treaty came into force in 2019. The reasoning was that voluntary cooperation on shared scientific work could build the trust regulators needed before they would formally recognise each other's decisions.

Results achieved

AMRH made regional approvals faster, particularly for priority medicines and during the COVID-19 pandemic, when joint reviews helped speed up access to vaccines and treatments. It is widely credited with creating the foundation for the African Medicines Agency, which is now being set up with Rwanda as its host country and progress on staffing and governance underway.

Two limits are worth noting. Building continental regulatory institutions takes time. The African Medicines Agency is still being made fully operational more than a decade after AMRH was launched. Not every African Union member state has ratified the treaty, which limits how widely the agency's decisions will be recognised. AMRH shows that regulatory harmonisation across many countries is possible. It does not show that it is quick.

The transferable lesson

Regulatory harmonisation across many countries is often described as a legal problem. In practice, it is a capacity-building problem. AMRH worked because it started with shared scientific work that was immediately useful to the regulators taking part. Regulators in smaller countries gained access to the expertise of larger ones. Regulators in larger countries gained a network they could rely on. The institutional structure of a continental agency came after that trust had been built. Initiatives elsewhere that try to start with a formal institution, hoping that trust will follow, tend to stall.