New regional drug regulator approves five products

For many years, Africa has faced significant challenges for instance from regulating medicines.

The first human medicinal products from Africa have been approved and listed by the African Medicines Regulatory Harmonization (AMRH).

The initiative aims to accelerate access to medicines for people in the AU member states by harmonising their national medicine-registration systems.

The achievement, announced on Thursday, is a historic milestone under the new Continental Procedure for Evaluation and Listing of Human Medicinal Products for the African Continent, which has been faced with a number of challenges.

For many years, Africa has faced significant challenges for instance from regulating medicines, fragmented approval processes growing threat of substandard and falsified medical products.

These barriers have slowed patient access to life-saving treatments and hinder market entry for innovative and locally manufactured medicines. The listing aims to strengthen regulatory oversight and enhance Africa’s ability to ensure medicines meet required safety, quality and efficacy standards.

Speaking on this achievement, Chimwemwe Chamdimba, head of the AMRH programme, said, "Beyond strengthening health systems for Africa, this achievement signals a turning point for Africa’s pharmaceutical industry, creating an environment that fosters innovation, attracts investment and accelerates regional trade in medicines. A harmonized regulatory approach streamlines processes for pharmaceutical manufacturers, enabling them to scale production and expand market access across the continent. This is a critical step in positioning Africa as a leader in pharmaceutical manufacturing, fully aligned with the African Union’s industrialization and trade goals under the African Continental Free Trade Area (AfCFTA) umbrella."

The Continental pilot was launched in November 2023, with the technical support of the European Medicines Agency (EMA), World Health Organization (WHO) and other partners.

The European Medicines Agency further contributed by providing technical expertise, leveraging its experience in coordinating regulatory systems through a well-established technical committee model. This collaborative effort has played a key role in reaching this important milestone.

Representing the European Medicines Agency (EMA) head of international affairs, Martin Harvey, commended this milestone saying: "It is truly thrilling to see these first outcomes of the continental joint assessment and General Manufacturing Practices (GMP) inspections. EMA has accompanied our AUDA-NEPAD colleagues along this journey, sharing our own experience of successfully bringing together experts from different countries. The success of AMA will depend on strong regional and national systems. Today is a historic milestone, and I look forward to a long and successful relationship between our two sister agencies, AMA and EMA.”