Context National health systems in sub-Saharan Africa lack sufficient and stable structures to regulate the sustainable supply of blood and blood products. Moreover, the availability of these products remains severely limited. These shortcomings pose significant health risks and contribute, among other factors, to high maternal and child mortality rates, whose…
Context Many African countries are striving to establish local vaccine production. However, a strong regulatory system is a prerequisite for the long-term success of this endeavour. This includes competencies to independently test and release locally produced vaccines. The project aims to provide safe and effective vaccines and biomedical medicines in…
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…
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…