European Journal of Biomedical and Pharmaceutical Sciences

ANALYZING THE FEASIBILITY OF ADOPTING THE HUMAN MEDICINES REGULATORY PATHWAYS OF THE EUROPEAN MEDICINES AGENCY FOR THE AFRICAN MEDICINES AGENCY

Khaled Hatem*, Prof. Dr. Werner Knöss, Dr. Peter Bachamann

ABSTRACT

The implementation of the Centralized Procedure (CP) among European countries was facilitated by the establishment of the European Medicines Agency (EMA) in 1995, which is a culmination of the efforts and milestones made during the harmonization of medicines regulation across Europe. Inspired by the success story of human medicines regulatory harmonization among European countries, the African Union (AU) established the African Medicines Agency (AMA). The objective of this article is to assess the feasibility of adapting regulatory procedures analogous to the EMA framework for the African context and to propose a flexible model tailored to the continent's specific needs. Data were collected using four methods, narrative review, scoping review, comparative analysis, and survey, based on the nature of the required data to assess the feasibility of developing harmonized mechanisms for human medicines approvals among African countries. The European regulatory pathways provide valuable preliminary models for regulatory harmonization in Africa. By using the European framework as foundational blueprint rather than initiating models from the ground up, African countries can accelerate the creation of unique and localized regulatory pathways. Harmonized legal bases are prerequisites for harmonized regulatory frameworks. Therefore, revising the AU Model Law on Medical Products Regulation is recommended, as harmonizing the regulatory frameworks on human medicines is overdue for all African countries. Furthermore, it should be referred to as a directive, as it is not directly binding. Comparative studies of each African country's legal and regulatory frameworks with the Model Law on Medical Products Regulation are advised. Moreover, it is recommended that the African Medicines Regulatory Harmonization (AMRH) initiative be restructured to operate through the Regional Coordination Centers (RCCs) rather than the Regional Economic Communities (RECs). Furthermore, independent monitoring and evaluation are necessary to ensure the success of regulatory harmonization of human medicines among African countries.

Keywords: Drug Regulatory Affairs; Regulatory Harmonization; African Medicines Agency; African Medicines Regulatory Harmonization; AU Model Law on Medical Products Regulation.