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…
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 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…
Short Description As the world comes together to tackle the COVID-19 pandemic, it is critical that essential services and operations continue to protect the lives of people with Tuberculosis (TB). The COVID-19 pandemic is expected to reverse much of the progress that has been made in reducing TB-related morbidity and…
Short Description The recurrent Ebola epidemics of recent years, as well as other infectious diseases widespread in Africa such as HIV, tuberculosis or malaria, show that effective and safe medicines for the prevention and treatment of these infectious diseases are not, or not sufficiently, available. Under the umbrella name “RegTrain”…
Short Description The Ebola epidemic in West Africa has shown that vaccines and therapeutics are not readily available to control an epidemic quickly. In many cases, health systems are overwhelmed under those conditions. Essential clinical trials can only take place with restrictions and delays, if at all. The RegTrain-VaccTrain project…
Joint guidelines: Ambitious work plan for 2021 and 2022 The four national medicines regulatory authorities (NMRAs) of Ghana (FDA Ghana), Liberia (LMHRA), Sierra Leone (PBSL) and The Gambia (MCA Gambia) are working as TWG-MAG members with the PharmTrain team in a joint effort to develop guidelines for marketing authorization. In…
Prior to the study visit After the successful fellowship at the BfArM with two colleagues from Ghana and Zimbabwe in 2019, the corona pandemic forced the project team to change plans. Already initiated preparations for a continuation of the onsite programme had to be dropped. Instead, with the Online Fellowship…