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…
Ghana aims to establish official lot release for vaccines and biological products Five Regulatory Officers from the Food and Drugs Authority of Ghana (FDA Ghana) took part in a two-week training at the Paul-Ehrlich-Institut (PEI) in February 2024. The participating team covered a range of expert areas:…
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 VaccRelease project supports African partner countries in establishing reliable official lot release to monitor the safety of vaccine lots. This includes: technical advice on analysing weaknesses using the WHO Global Benchmarking Tool, developing country-specific regulatory structures such as regulations, guidelines, and standard operating procedures, building competencies as needed. Training…
‘We need to collaborate! Let’s go far together.’ Under the leadership of the African Union, the African continent is working hard to expand its own vaccine production. At the same time, this requires strict state control and monitoring of locally produced vaccine lots. As for regulatory authorities and official control…
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…
Context Vaccines remain the most effective tool for preventing infectious diseases and for improving global health. As only 1% of the vaccines needed in Africa are currently produced in Africa, the continent needs a robust vaccine industry. The COVID-19 pandemic, in particular, has highlighted the need for supranational structures to…
Context The Ebola epidemic and the COVID-19 pandemic have clearly demonstrated that timely access to safe, effective and affordable medicines and vaccines is vital to prevent and fight infectious diseases and protect public health. Many African countries, however, rely on imports of vaccines because national production capacity is insufficient and…