Context Rising outbreaks of infectious diseases, growing antimicrobial resistance and chronic diseases pose major challenges to health systems worldwide. Strong, well-functioning medicines regulatory authorities help ensure that people can access safe, effective and quality-assured medicines and vaccines in time. This supports a reliable drug supply and reduces pressure on healthcare…
Context In many countries in Western and South-Eastern Africa, access to safe and effective medicines remains a challenge. A key factor is the limited capacity of national drug quality control laboratories. Insufficient structures, resources or standardised procedures hinder reliable quality testing. As a result, substandard or falsified medicines may reach…
The 7th Scientific Conference on Medical Product Regulation in Africa (SCoMRA) was held in Mombasa, Kenya, from 10 to 14 November 2025. It was organised by the African Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD). The conference offered an ideal platform for PharmTrain2 to showcase its…
In many African countries, access to essential medicines depends heavily on their affordability. Hence, generic and biosimilar medicinal products play a key role. These products, typically less expensive due to reduced development costs, are vital to achieving equitable healthcare (High Interest in the PharmTrain2 Fellowship: A Tailor-made…
The PharmTrain clinical fellowship involves fellows from the national medicines regulatory authorities (NMRAs) in Ghana, Zimbabwe, Tanzania and South Africa, i.e. from three different economic regions, thus covering large parts of Sub-Sahara Africa. This group committed to an intensive, multi-year journey to acquire both technical expertise and didactic skills within…
Context Low-quality drugs pose a substantial threat to individual and public health. Issues include incorrect labelling, potentially toxic or wrong active ingredients and unacceptably high levels of impurities. Low-quality anti-infective medicines, in particular, pose a potentially global concern as they can lead to the development of antimicrobial resistance, making the…
Biosimilars and their importance for the African Continent Biotechnologically manufactured medicines are becoming more and more important, especially for the treatment of cancer, diabetes, and viral diseases. These products are often very expensive due to their complex development and manufacturing processes. However, after a certain period, these products may be…
The AMRH Week: A landmark in the operationalization of the African Medicines Agency PharmTrain, a technical partner of the African Medicines Regulatory Harmonization (AMRH) initiative, and member of the Coalition of Interested Parties (CIP), participated in the “3rd AMRH Week” in Accra, Ghana in December 2022. This biennial conference is…
Context Global health crises are on the rise, especially those caused by infectious disease outbreaks, and pose a serious threat to health and well-being. WHO estimates that up to 10 million lives could be saved every year if access to safe and effective medicines and vaccines were improved. As a…