Progress in Regulations and Ethics

Sub-Saharan African countries have stepped up efforts to strengthen product development and marketing authorisation regulations. For example, in Nigeria, the agency (NAFDAC) has revised most of its regulations regarding clinical trials, products importation and requirements for marketing licences. NAFDAC has also vetted and registered several independent experts and organisations that will serve as consultants. The role of these individuals and enterprises are to augment the Agency’s manpower resources so as to deliver on its promise of providing robust regulatory oversight. It is worth noting that most of these regulatory requirements are essentially based on ICH GCP and/or adaptations of those of FDA and EMA.

Most tertiary medical centres in Nigeria have local ethic committees/independent review boards. These are in addition to the national central committee. Through the efforts of bodies such the EDCPT, African ethic committees have received help in terms of training and resources to enable them function effectively. Clinical trials clearance by ethic committees can now be obtained through online applications in Nigeria. There have been other positive initiatives particularly in Nigeria and Ghana which clinical trials sponsors will be happy with.