Comparative Pharmaceutical Regulatory Affairs Database of African Countries

This database presents a structured comparative analysis of the pharmaceutical regulatory systems in African nations from the standpoint of regulatory affairs. Some of the important parameters being analyzed are the regulatory authorities of each nation, legislative environment, methods of obtaining marketing approval, clinical trials, pharmacovigilance, GMP conformity, regulatory reliance, digitalization, and post-market monitoring. The scope of the analysis also includes emerging issues of regulation that deal with biosimilars, vaccines, advanced therapy medicines, herbal medicines, nanomedicines, and combination products. As a result of the systematic ordering of regulatory frameworks and levels of development of regulations, the database makes it easier to compare different countries and draw conclusions on regulatory strategy.