Evaluation of the Regulatory Review Process of the Zambia Medicines Regulatory Authority: Challenges and Opportunities
This study assessed the overall ZAMRA operation and identified the key milestones in the review process for products approved from 2020 to 2023, target timelines achieved and the compliance to standard good review and quality decision-making practices.
Authors
- Makomani Siyanga
- Stuart Walker (ORCID: https://orcid.org/0000-0002-7688-5306)
- Adem Kermad
- 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
- Therapeutic Innovation & Regulatory Science
- Published
- 2024-12-27
- DOI
- https://doi.org/10.1007/s43441-024-00730-6
- Citations
- 2
- Primary Topic
- Pharmaceutical Quality and Counterfeiting
- Type
- article
- Field-Weighted Citation Impact
- 1.09
Funders
- Bill and Melinda Gates Foundation