The BloodTrain Next Generation team trained twelve regulators from six African medicines regulatory authorities at the Paul-Ehrlich-Institut (PEI) from 20 to 31 October 2025. The participants deepened their knowledge in the regulation of blood screening in vitro diagnostic medical devices (IVDs) through practical training with PEI IVD experts. They particularly…
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…
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…
‘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…
Since 2019, the World Health Organization (WHO) has included the regulation of blood and blood products in its global assessment system for medicine authorities, the Global Benchmarking Tool (GBT). Until now, no official WHO benchmarking using the extended GBT + Blood tool has been performed. However, the self-assessment using this…
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 The availability, safety and quality of blood and blood products is an essential component of any health care system. The WHO has therefore listed them as essential medicines. Blood products are life-saving for many patients, in particular for women with pregnancy-related complications, children suffering from severe anaemia and people…
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…