Evaluation of the review models and approval timelines of authorities participating in the East African Medicine Regulatory Harmonisation initiative: alignment and strategies for moving forward
The study has provided a baseline for review models, target timelines and data requirements utilised in assessing applications for registration by EAC-MRH NRAs. Implementing the recommendations from this study will enable the NRAs to align and improve their registration processes.
Authors
- Nancy Ngum
- Clarisse Irasabwa
- Sam Salek (ORCID: https://orcid.org/0000-0002-4612-5699)
- Stuart Walker (ORCID: https://orcid.org/0000-0002-0667-6373)
- Margareth Ndomondo-Sigonda (ORCID: https://orcid.org/0000-0002-0395-063X)
- Rémy Habonimana
- Sabrina Ahmada
- Julia Ojukwu
- Felchism Apolinary
- Fred Siyoi
- Andrew Okello
Institutions
- University of Hertfordshire (GB)
- Republic of Burundi (BI)
- Pharmacy and Poisons Board (KE)
- Zanzibar University (TZ)
- Centre for Innovation in Regulatory Science (GB)
- African Union (ET)
- Ministry of Health, Community Development, Gender, Elderly and Children (TZ)
- Rwanda Development Board (RW)
- State University of Zanzibar (TZ)
Publication Details
- Journal
- Frontiers in Medicine
- Published
- 2024-09-17
- DOI
- https://doi.org/10.3389/fmed.2024.1438041
- Citations
- 5
- Primary Topic
- Pharmaceutical Economics and Policy
- Type
- article
- Field-Weighted Citation Impact
- 5.65
Funders
- Bill and Melinda Gates Foundation