Assessment of compliance with good review practices by medicine assessors within the Zambia medicines regulatory authority
This study has successfully determined the GRevPs used in the review process and their implementation by ZAMRA. It has provided a reference point from which the ZAMRA can work towards improvement as a means to enhance regulatory performance. The findings of this study will form the basis of development for the NRA as it strives to achieve the WHO Maturity Level 3 status.
Authors
- Makomani Siyanga
- Stuart Walker (ORCID: https://orcid.org/0000-0002-0667-6373)
- Neil McAuslane
- S. Rebecca Leigh
- Constance Sakala Chisha
Institutions
- University of the Witwatersrand (ZA)
- Centre for Innovation in Regulatory Science (GB)
- World Health Organization - Zambia (ZM)
Publication Details
- Journal
- Frontiers in Medicine
- Published
- 2025-11-11
- DOI
- https://doi.org/10.3389/fmed.2025.1706139
- Primary Topic
- Pharmaceutical Quality and Counterfeiting
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Bill and Melinda Gates Foundation