Moving Tanzania’s Clinical Research Ethics and Medicines Regulatory Capacity to the next level: Fostering Medicine Quality, Safety and GCP Clinical Trials (ASCEND)

The volume of clinical research in Tanzania has increased rapidly in the last 10 years and so has the demand on research ethics committees and medicines regulators to approve and monitor research. In the same vein the rise in occurrence of highly infectious diseases, such as Ebola, Chikungunya, etc, that have no approved therapy have tested the readiness of ethics committees and medicine regulators across Africa. The need for ethical and regulatory capacity to respond in a timely manner cannot be emphasised more. Through our EDCTP funded SMERT grant (EDCTP-CSA-Ethics-1432-SMERT), some progress has been made resulting in establishment of electronic systems to expedite research ethics review at the National Health Research Committee and reporting of adverse drug events in clinical trials. Despite this progress, there are still substantial gaps that ASCEND will address in order to make Tanzania ready to ensure quality and safety of medicines and performance of Good Clinical Practice (GCP) compliant clinical trials. The concept of research ethics and pharmacovigilance remains abstract to the majority in the community, which consequently compromises the effectiveness of ensuring ethical research and reporting of adverse drug events (ADEs). ASCEND will use the opportunity to sensitise members of the public on their rights and responsibilities to question the ethics of research they are participating in and to report any ADE. Tanzania Medicines and Medical Devices Authority (TMDA) and Muhimbili University of Allied Health Sciences (MUHAS) are Regional Centres of Regulatory Excellence (RCOREs) for medicines evaluation and excellence with a mandate of enabling national medicines regulatory authorities (NMRA) to develop their medicines regulatory capacity. Sadly, the RCORE itself lacks the capacity to achieve their mandate. ASCEND will support the MUHAS/TMDA RCORE to develop human and infrastructural capacity to perform their duties. Harmonisation of medicines evaluation guidelines across East Africa will be proactively sought. Zanzibar, one of the nations that form the United Republic of Tanzania, has recently established their national research ethics committee and medicines regulatory authority, which still require a lot of capacity building to effectively execute their mandated duties. Through ASCEND, ethics committee members and pharmacovigilance monitors will be trained and a mentoring scheme put in place to ensure sustainable capacity building beyond the ASCEND project.