Masterarbeit
Towards Harmonised Medicine Regulation in Africa: Analysing the Feasibility of Adopting the Centralised Procedure of the European Medicines Agency for the African Medicines Agency ***
Khaled Hatem (2024)
Summary
Language: English
Background: The implementation of the Centralised Procedure (CP) among European countries was facilitated by the establishment of the European Medicines Agency (EMA) in 1995. Inspired by the success story of human medicines regulatory harmonisation among European countries, the African Union (AU) established the African Medicines Agency (AMA).
Aim of Thesis: This thesis explores the feasibility of introducing the EMA's CP or similar mechanisms for approving human medicines in Africa, leveraging the positive momentum generated by the formation of the AMA.
Methods: Based on the required data type, the data for this research were collected using four methods: narrative review, scoping review, comparative analysis, and survey.
Results: Europe's harmonised regulatory frameworks represent some of the most advanced systems globally. These frameworks facilitate the authorisation of human medicines using various legal instruments with differing degrees of binding force to support the functionality of the EMA's operations. On the other hand, harmonisation efforts among African countries are still in the early stages. Moreover, the lack of a clear and binding legal basis is challenging. Furthermore, the human and financial resources allocated to support the regulatory harmonisation of human medicines among African countries are inadequate.
Conclusion: Adopting the EMA's CP among African countries may pose a significant challenge. However, it could be strategically developed for human medicines used in pandemic situations, such as COVID-19 vaccines during recent outbreaks. Therefore, the EMA's CP is helpful as a preliminary model for developing suitable mechanisms among African countries. There is considerable potential to develop unique regulatory pathways among African countries. There is no need to start from scratch when developing a harmonised regulatory system, as the European regulatory framework can provide a foundational blueprint.
Harmonised legal bases are prerequisites for a harmonised regulatory framework. Therefore, revising the AU Model Law on Medical Products Regulation is recommended, as harmonising the regulatory frameworks on human medicines is overdue for all African countries. Although this is referred to as a regulation, it is not directly binding. Therefore, it should be referred as a directive.
Comparative studies of each African country's legal and regulatory frameworks with the Model Law on Medical Products Regulation are advised. Furthermore, it is recommended that the African Medicines Regulatory Harmonisation (AMRH) initiative be restructured to operate through the Regional Coordination Centres (RCCs) rather than the Regional Economic Communities (RECs).
Furthermore, independent monitoring and evaluation are necessary to ensure the success of regulatory harmonisation of human medicines among African countries. The aim is to achieve an advanced status that allows for the implementation of procedures similar to those of the European human medicines regulatory system and, at the most advanced stage, similar to the EMA's CP.
Pages: 119
Appendices: 3, Pages: 28