Suggested Improvements to the Current East African Community Medicines Regulatory Harmonization Joint Review Process and a Proposed New Review Model for this Initiative
The EAC-MRH initiative can only be effective and efficient if the NRAs in the region are operating at an optimal level. Therefore, proposals were made to address the gaps identified in the regulatory review processes of the EAC NRAs and to improve effectiveness and efficiency. Importantly, a centralised submission and tracking process was proposed as the new and improved model for the EAC-MRH initiative.
Authors
- Burhani Othman Simai (ORCID: https://orcid.org/0009-0009-3489-5782)
- Nancy Ngum
- Chimwemwe Chamdimba (ORCID: https://orcid.org/0000-0002-9016-4193)
- Sam Salek (ORCID: https://orcid.org/0000-0002-4612-5699)
- Adam Mitangu Fimbo (ORCID: https://orcid.org/0000-0002-9356-2218)
- Stuart Walker (ORCID: https://orcid.org/0000-0002-7688-5306)
- Emile Bienvenu (ORCID: https://orcid.org/0000-0002-1555-7376)
- David Nahamya
- Fred Siyoi
- Dedith Mbonyingingo
- Mawien Atem
Institutions
- University of Hertfordshire (GB)
- Republic of Burundi (BI)
- Kampala Capital City Authority (UG)
- Pharmacy and Poisons Board (KE)
- Zanzibar University (TZ)
- Hernia Center (US)
- Centre for Innovation in Regulatory Science (GB)
- Rwanda Development Board (RW)
Publication Details
- Journal
- Pharmaceutical Medicine
- Published
- 2025-03-01
- DOI
- https://doi.org/10.1007/s40290-025-00554-1
- Primary Topic
- Pharmaceutical Economics and Policy
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Bill and Melinda Gates Foundation