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P226: A Comparison of the Regional Medicines Regulatory Harmonisation Projects in East, West and Southern Africa

Poster Presenter

Stuart Russel Walker

Professor and Consultant
Centre for Innovation In Regulatory Science (CIRS)
United Kingdom

Objectives

The objective of this study was to compare the operating models, successes and challenges of three of the medicines regulatory harmonisation (MRH) projects being implemented in Africa through the African Medicines Regulatory Harmonisation initiative (AMRH).

Method

Data were collected in 2021 and 2022 using the Process, Effectiveness and Efficiency Rating questionnaire (PEER) developed by the authors and from existing literature. The national regulatory authorities (NRAs) of 23 countries from the three regions participated in the study (100% response rate).

Results

The research was exploratory and hypothesis generating. The study compared the operating models (i.e., type of review procedure, legal framework, eligibility criteria for joint review, submission windows, submission process, assessment / review process, communication with sponsors, final approval and marketing status, target timelines for joint review, target timeline for registration by NMRA after a regional recommendation and fees payable) of three medicines regulatory harmonisation (MRH) projects, EAC MRH, ZaZiBoNa / SADC MRH and ECOWAS MRH implemented in Africa since 2012, 2013 and 2017 respectively. The study also identified and compared the successes and challenges of the MRH projects. One of the findings was that although the MRH projects were established at different times and at the discretion of each region, the operating models are largely similar with a few differences including key being the process for submission of applications for joint review. In ECOWAS, submission is made to a regional administrative body and only submitted to the individual participating countries after the regional joint review, while in EAC submissions are made to one lead country responsible for registration and then to the remaining participating countries only once the review is completed. In ZaZiBoNa/SADC submissions are made to each individual participating country of interest from the outset and prior to the joint review. The participants were of the view that the AMRH has achieved its goals to strengthen regulatory systems and harmonise regulatory requirements in the economic regions of Africa through the MRH projects. This has also resulted in a reduced burden for pharmaceutical industry and improved access to quality assured medicines for patients but not necessarily at a lower cost. The challenges identified in the three regions are also similar and the most noteworthy one is the lack of a binding legal framework for a centralised procedure and regional approvals.

Conclusion

The MRH projects through the joint reviews have succeeded to meet their core objectives which were to harmonise guidelines and registration requirements and to build the capacity of member states. The objectives of shorter timelines for registration and simultaneous access to various markets for manufacturers have not been as straightforward to achieve for all three regions as they are dependent on the time taken by the individual countries to issue a registration / marketing authorization upon completion of the joint scientific review and additionally for EAC MRH and ECOWAS MRH the time taken by the applicant to submit an application for registration of a jointly reviewed product to the individual countries. The European Medicines Agency (EMA) which has been in existence for over 25 years provides a blueprint from which the regional harmonisation projects in Africa can learn. The study identified opportunities for improvement and alignment in the following areas: • Alignment of the operating models of the three MRH projects to improve efficiency • Development of legal frameworks for regional centralised procedures • Improved communication with applicants including the publishing of expressions of interest by all regions • Use of robust Information Management Systems (IMS) • Strengthening of the regulatory capacity of member states to facilitate greater reliance among countries within one region as well as between regions. This study has highlighted the successes of the MRH projects in Africa as well as opportunities for improvement and alignment. It is acknowledged that the AMRH is the initiative underpinning the operationalisation of the African Medicines Agency (AMA). The results of this comparison allow the three regions to learn from each other, and implementation of the recommendations will bring greater alignment and efficiency in their operating models thereby supporting the foundation of the AMA.