Gaborone, Botswana, four products successfully listed under harmonised continental procedures marking a milestone for regulatory efficiency and access to quality medicines in Africa Botswana has emerged as one of the key beneficiaries of the Continental Pilot for Evaluation and Listing of Human Medicinal Products led by the African Medicines Regulatory Harmonisation (AMRH) Programme of the African Union Development Agency (AUDA-NEPAD). Through this pilot, four medicinal products have now been listed and registered in Botswana, a milestone that demonstrates the country’s growing capacity to adopt continental harmonised regulatory systems and fast-track access to quality-assured medicines for its population.
The pilot, jointly implemented by the Evaluation of Medicinal Products Technical Committee (EMP-TC) and the Good Manufacturing Practices Technical Committee (GMP-TC) under the African Medicines Regulatory Harmonisation Programme (AMRH) at AUDA-NEPAD, has significantly streamlined the product evaluation and listing process across participating countries. What previously could take up to six years for a medicine to be registered in multiple African countries can now take as little as two weeks under the new harmonised continental procedure — a game-changer for health systems and patients alike.
“Botswana’s achievement shows what is possible when national regulatory authorities work hand-in-hand with continental structures,” said Chimwemwe, Head of the AMRH Programme at AUDA-NEPAD.
Hosting this week’s joint EMP-TC and GMP-TC meeting in Gaborone (29–31 October 2025), Botswana provides a fitting backdrop to celebrate the outcomes of the pilot and to chart the next phase of regulatory alignment as AMRH transitions toward the African Medicines Agency (AMA).
“Botswana’s achievement shows what is possible when national regulatory authorities work hand-in-hand with continental structures,” said Chimwemwe, Head of the AMRH Programme at AUDA-NEPAD. “Through the leadership of the GMP-TC and EMP-TC, Africa is proving that it can shorten medicine registration timelines from years to weeks. This is not just an administrative success — it’s a powerful step toward ensuring equitable access to safe, effective, and quality-assured medicines across our continent.”
The listing of the four products in Botswana represents more than regulatory progress — it signals:
- Faster access to essential and innovative medicinal products for patients in Botswana and the region.
- Enhanced confidence in regional reliance mechanisms and joint assessments; and
- Greater alignment with the African Medicines Agency’s vision for a single, harmonised African regulatory system.
“The success of this pilot is evidence that Africa can lead in regulatory innovation,” added Chimwemwe. “Botswana’s role as host and beneficiary is a testament to its growing leadership in strengthening medicines regulation and advancing the continental health agenda.”
