Objectives

1. To investigate ways in which the regional initiative could be well coordinated.
2. To propose an improved model for the East African Medicine Regulatory Harmonisation Initiative joint assessments.
3. To initiate inspection processes for the operationalisation of the African Medicines Agency (AMA).

Methods

Three established standardised questionnaires were completed by the head of the medicine’s registration division in each of the seven National Regulatory Agencies (NRAs) as well as pharmaceutical industry companies that had used the EAC-MRH process for the review and approval of their applications.

Results

The East African Community Medicines Regulatory Harmonization (EAC-MRH) regional initiative consists of seven agencies, namely Burundi, Kenya, Uganda, Rwanda, South Sudan, Tanzania and Zanzibar. The results showed that the regulatory review processes of these authorities vary and require further alignment. For example, clock stop time, which varies from country to country makes it difficult to compare the actual review timelines against target timelines. The study underlined the need to invest in regulatory systems strengthening, streamline country processes and minimise the differences between NRAs to improve the effectiveness and efficiency of the EAC-MRH work-sharing initiative. Benefit-Risk Assessment should be used by the NRAs to improve transparency and accountability in line with good review practices as well as being empowered to be able to review applications of novel medicines. The implementation of a robust Regulatory Information Management System (RIMS), with 90 calendar days target timeline to register products after regional recommendation and reliance are critical for NRAs. The number of applications received by the EAC-MRH for joint reviews increased from nine applications in 2015 to 44 applications in 2023, while the median review time reduced from 553 calendar days in 2015 to 259 calendar days in 2023. A key benefit for pharmaceutical companies using the work-sharing initiative is the need to prepare only one application for submission and eventual access to several markets simultaneously. An improved model has been proposed which entails a centralised submission with a simplified review process, and predictable timelines, with the centralised payment of fees that will make the process more attractive over the standard pathway. The utilisation of reliance and the timelines for using the centralised procedure from application to recommendation for NRAs to grant marketing authorisation will reduce from the current 360 days to 210 calendar days.

Conclusion

The EAC-MRH centralised process will act as an interphase between the national and continental (AMA) review processes. It is hoped that this proposed improved model, if implemented, will eventually lead to the successful implementation of the EAC-MRH work-sharing programme with minimal challenges.
Recommendations:
  1. NRAs to grant marketing authorisation within target timelines: This should be within a maximum of 90 calendar days following the regional recommendation and submission of application to the agencies. Data from the regional reviews should be provided to the NRAs together with their recommendation for registration so that countries can expedite marketing authorisation.
  2. Implement the Sustainability Plan: This plan which was approved by the Ministers of Health in 2024 should be implemented to ensure that the EAC-MRH Initiative is self-sustainable and not dependent on donor funds.
  3. Set number of Cycles for the Review Process: The time points for manufacturers to respond to queries should be 60 calendar days for the first queries and 30 calendar days for the second query. The review cycle should be reduced from three or four cycles to two cycles.
  4. Implement Inter-REC Reliance: This should be implemented to fast track review timelines. The work-sharing pathway should allow for possible reliance on decisions from other regional joint assessments
  5. Communication with Applicants: It is important to conduct stakeholder consultations in order to attract more applications. It will be helpful to perform online webinars to attract new applicants and to create an awareness of the joint review sessions.
  6. Implement a Regulatory Information Sharing Portal: The MRH programme should publish all recommended products on their website and implement the AMRH Regulatory Information Sharing Portal (RISP) that will enable the Initiative to share regulatory information and knowledge exchange on the continent.

This poster by Nancy Ngum, Chimwemwe Chamdimba, Dedith Mbonyingingo, Fred Siyoi, Emile Bienvenu, Mawien Atem, Adam Fimbo, David Nahamya, Burhani Simai, Stuart Walker and Sam Salek was presented at the 2025 DIA Global Annual Meeting, 16-20 June 2025, Washington DC, USA.

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