Zimbabwe Profile Updated
The Zimbabwe profile in ClinRegs has been reviewed and updated with the following information, which is current as of November 12, 2025:
- Medicines Control Authority of Zimbabwe (MCAZ) regulatory fee schedule, which took effect September 1, 2025 (See Regulatory Fees)
- Updated MCAZ pharmacy guidelines (See Manufacturing & Import)
- Updated MCAZ guidelines on clinical trial application and authorization procedures (See Scope of Assessment, the Clinical Trial Lifecycle topic, and the Sponsorship topic)
- Updated MCAZ good clinical trial practice guidelines (See Scope of Assessment, Safety Reporting, and the Sponsorship topic)
- MCAZ guidelines on using the reliance pathway for clinical trial application review (See Scope of Assessment)
- MCAZ webpages for online services and clinical trials oversight guidelines, application forms, and public assessment reports (See Regulatory Authority and Manufacturing & Import)
- Background and contact information for the National Biotechnology Authority of Zimbabwe (See Regulatory Authority)
- Updated review timeline for the Research Council of Zimbabwe (See Timeline of Review)
- Updated MCAZ user manual for the pharmacovigilance reporting system (See Additional Resources)
- University of Zimbabwe’s updated SOP for regulatory communication with regulatory bodies (See Additional Resources)
Sources Added During this Update:
(Guidance) Reliance Guidelines for Regulation of Medicines (G-Reliance) (Effective March 24, 2025)
Medicines Control Authority of Zimbabwe
(Webpage) Clinical Trial’s Oversight (CT) (ZWE-14) (Current as of November 12, 2025)
Medicines Control Authority of Zimbabwe
(Webpage) National Biotechnology Authority – Contact (ZWE-16) (Current as of November 12, 2025)
National Biotechnology Authority of Zimbabwe
(Webpage) Online Services (ZWE-15) (Current as of November 12, 2025)
Medicines Control Authority of Zimbabwe
Sources Revised During this Update:
(Circular) Circular No. 24 of 2025 – Fee Schedule (CT-Fees) (Effective September 1, 2025)
Medicines Control Authority of Zimbabwe
(Guidance) Guidelines for Clinical Trial Application and Authorization in Zimbabwe (MCAZ-PVCT-GL-04) (CT-AppAuth) (Revision 2) (Effective August 30, 2024)
Medicines Control Authority of Zimbabwe
(Guidance) Guidelines for Good Clinical Trial Practice in Zimbabwe (MCAZ/PVCT/GL-05) (ZWE-GCP) (Revision 3) (Effective August 30, 2024)
Medicines Control Authority of Zimbabwe
(Guidance) Pharmacy Guidelines for Investigational Medical Products (Pharm-IMPs) (Version 2) (Effective November 29, 2023)
Medicines Control Authority of Zimbabwe
(Document) Electronic Pharmacovigilance Reporting System External User Manual (Revision 1) (ZWE-87) (October 2024)
Medicines Control Authority of Zimbabwe
(Document) SOP for Managing and Documenting Regulatory Communication with Regulatory Bodies (ZWE-74) (Version No. 12.0) (March 13, 2025)
University of Zimbabwe
(Not Available Online) NIAID Communication with University of Zimbabwe (September 2025) (ZWE-83)
(Webpage) MCAZ Online Services Portal (ZWE-82) (Current as of November 12, 2025)
Medicines Control Authority of Zimbabwe
(Webpage) National Biotechnology Authority – About Us (ZWE-67) (Current as of November 12, 2025)
National Biotechnology Authority of Zimbabwe