groups » Regulations and Guidelines » Introducing an online module on regulatory Affairs for African researchers, scientist and regulators
Regulatory requirements form an integral part in the drug discovery and development process. These requirements outline a set of criteria that a new medicinal product must conform to before being approved for marketing in any country. In line with these requirements, all clinical trials in humans aimed at developing a new product must be approved by a competent regulatory authority. In addition, the approving authority must strictly supervise these trials to ensure that they are conducted in accordance with GCP, the applicable regulatory requirements and the legal rules in the county involved. However, according to WHO, 90% of African countries lack the capacity to carry out medicine regulatory functions, including the review, approval and supervision of clinical trials as well as analysis and interpretation of clinical trial results. In addition, 84% of countries do not have clear legislation on clinical trials; even the few that have legislation, most do not assign a clear mandate to a specific body. To fill this gap, organisations like WHO (through AMRHI and AVAREF) and the European and Developing countries clinical trial partnership (EDCTP) have been spear-heading efforts to strengthen regulatory capacity in several African Countries. Although these concerted efforts have had a significant impact in building regulatory capacity in a number of countries, the coverage is still not satisfactory. Therefore, to reach a wider audience, the Global Health Trials Website is proposing to introduce a new online module on regulatory affairs. The objective of this module is to provide basic information on regulatory affairs to African researchers, scientist and regulators so as to enhance good regulatory practices and to facilitate the development of regulatory sciences in the continent.
We would be glad to get your input on the key topics that you may want to feature in this online module.