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:…
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…
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…
Haemovigilance comprises a complex system for monitoring the entire blood transfusion chain from blood collection to transfusion and the follow-up of transfused patients. It serves to ensure the safety and improved use of blood and blood products. By working on the development of haemovigilance systems in Africa, BloodTrain has gained…
As part of its official mandate the Liberia Medicines & Health Products Regulatory Authority (LMHRA), conducted a GCP Joint inspection at one of the country’s most active clinical trial site where a new candidate vaccine is being assessed. For this inspection, the LMHRA invited the VaccTrain 2.0 team to serve…
Needs-based plan for building structures and skills VaccTrain continues to support its partners in building regulatory capacity during the second phase of the GHPP. The VaccTrain team visited three of its five partner countries, The Gambia, Liberia, and Sierra Leone, between February and July 2023. During this, the project teams…
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 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…