Evolution of Clinical Trial Regulations in Cote D’Ivoire

Clinical trials are an essential step in bringing innovative medicines to market. Their effective regulation, which protects participants in these trials, is important in West African’s heavy dependence on foreign sources for medicines context, and particularly in Côte d’Ivoire where the government has expressed its desire to develop the local pharmaceutical industry, including innovation. The objective of this study was to describe the regulations governing clinical trials in Côte d’Ivoire. The methodology used consisted in identifying and then analyzing the applicable texts to clinical trials as well as the reports emanating from the bodies involved in the regulation of clinical trials. The results of our study reveal that in Côte d’Ivoire, since 1987, clinical regulation trials, characterized by the creation and organization of the main bodies in charge of managing these trials, has not really evolved. It took about thirty years to observe a major evolution in regulations with the adoption of Presidential Decree No. 2020-407 of April 22, 2020 regulating clinical trials in Côte d’Ivoire. This salutary text incorporates general principles universally accepted in this area such as the protection of persons and their free and informed consent before any testing is conducted. This confirms the role of the Ivorian Pharmaceutical Regulatory Authority in clinical trials monitoring, while still considering National Ethics Committee mandatory opinion. This development in Ivorian regulations is part of a sub-regional project to regulate clinical trials and will become effective with implementing regulations adoption.