Kenya joins continental push to end drug approval delays in Africa
Delegates follow proceedings during the 7th Scientific Conference on Medical Product Regulation in Africa at Pride Inn Paradise in Mombasa on November 11, 2025. They are discussing faster approval of medicines and diagnostics under the African Medicine Agency.
What you need to know:
- For Kenya, it means patients can access essential medicines much faster without compromising safety.
The Pharmacy and Poisons Board (PPB) has joined other national regulators in a continental plan to speed up the approval of medicines and diagnostic kits.
This critical step comes as the continent prepares to launch the new African Medicines Agency (AMA), which aims to facilitate patient access to effective, safe and high-quality medicines on the continent.
The move is part of the African Medicines Regulatory Harmonisation (AMRH) programme, which has completed pilot projects on how African countries can work together in approving medical products for emergency and routine use.
Speaking during the 7th Scientific Conference on Medical Product Regulation in Africa in Mombasa, Pharmacy and Poisons Board's (PPB) Head of Registration and Evaluation Health Products and Technologies, Dr Kariuki Gachoki, said the goal is to ensure Africans get quick access to safe, effective and quality-assured medical products, while cutting delays caused by different national approval systems.
He noted that so far, 12 medicines have been cleared and published in the AMHR Green Book -a publicly available resource that provides information on medicines scientifically evaluated for safety, efficacy, and quality - which is being used by several countries to speed up local registration. Dr Gachoki said the harmonised approach will help smaller agencies benefit from shared expertise and avoid duplication.
“This initiative will save time and resources by allowing us to rely on each other’s scientific assessments. For Kenya, it means patients can access essential medicines much faster without compromising safety.”
The initiative is supported by the African Union Development Agency, the World Health Organization, the Africa Centres for Disease Control and Prevention, and the European Medicines Agency.
Since 2023, AMRH has worked with national regulators, including Kenya’s PPB, to test a common system for listing medicines.
In a related effort, AMRH’s Medical Devices Assessments Technical Committee launched an emergency-use approval process for Mpox diagnostic kits. The process attracted 11 applications, and three kits were approved for emergency use in July 2025.
The Mpox experience has provided valuable lessons that will guide the continent-wide listing of diagnostics expected to begin in 2026.
Approval procedures
As AMRH’s technical work transitions into the African Medicines Agency, regulators and industry representatives will hold an industry engagement day to review progress, close the pilot phase, and plan the next steps.
The conference, which has delegates from all 55 African states, will also discuss a proposed fee-for-service model and ways to simplify approval procedures at national, regional and continental levels. Discussions will also focus on ways to strengthen local manufacturing and trade of medicines, vaccines, and protective equipment.
African Medicines Agency Director General, Dr Delese Darko, stated that the agency will be pivotal for Africa's health security and its goal to boost local pharmaceutical manufacturing.
“The agency will make it easier for quality medical products to reach all Africans quickly and safely. It will also strengthen trust in locally made medicines and open up opportunities for trade under the African Continental Free Trade Area,” said Dr Darko.
He emphasised the role of a single continental regulatory agency. “The AMA will provide faster access to medicines, as we saw was needed with vaccines during Covid-19, and it will allow local agencies to thrive. Tests for diseases like Mpox or Covid can now be manufactured under the AMA’s umbrella.”
PPB Chairperson Jon Munyu emphasised the need for Africa to manufacture its own medicines to improve accessibility and eliminate substandard products..
He said the combined efforts of AMRH and AMA will reduce dependence on imports, tackle counterfeit drugs, and make Africa self-reliant in producing and distributing life-saving products.
Health experts say the harmonised system will not only improve Africa’s ability to respond to public-health emergencies but also make the continent more self-reliant in producing and distributing life-saving products.
At the same time, Symerre Johnson, director-general of African Union Development Agency- New Partnership for Africa's Development, said Africa faces a growing challenge of falsified and substandard medicines.
Stressing the needs of a population of 1.54 billion, he emphasised that a harmonised regulatory system is critical.
“With the African Medicines Agency in place, we can regulate what we produce and produce what we regulate.This will promote local manufacturing of essential medicines, vaccines, and protective equipment, ensuring Africa is not only a manufacturer but also an exporter.”
He highlighted the need to de-risk Africa for investors through the new Programme for Investment and Financing in Africa’s Health Sector, an initiative aimed at encouraging financing and boosting local production.
Johnson noted that Africa currently imports most basic medicines for women, children, and babies, a situation he described as a tragedy. He added that of the continent's 600 local manufacturing sites, only 52 can complete the full production cycle.
“We have 24 essential medical products identified for investment, covering basic medicines like cough syrup, antibiotics, Panadol, and snake bite treatments.”
