Zimbabwe Profile Updated
The Zimbabwe profile in ClinRegs has been reviewed and updated with the following information:
- Additional details on the Medicines Control Authority of Zimbabwe (MCAZ)’s reliance model from its 2024 policy (See Scope of Assessment)
- Additional details related to MCAZ application requirements and review timeline (See Submission Content and Timeline of Review)
- Research Council of Zimbabwe (RCZ) requirements for translation of research materials (See Submission Process and Documentation Requirements)
- Details on RCZ’s expedited review of foreign researchers’ clinical trial applications (See Scope of Assessment and Submission Content)
- Additional details on organization types recognized by the RCZ for foreign researchers to affiliate with when applying for clinical research approval (See Submission Process)
- Additional details on Medical Research Council of Zimbabwe (MRCZ) application submission requirements and process for amending or modifying a research study (See Scope of Review and Submission Process)
- Details on MCAZ clinical trial authorization renewal and MRCZ annual review (See Scope of Assessment and Scope of Review)
- Updated MCAZ forms and proposal checklist, which underwent minor revisions (See Forms)
Sources Added During this Update:
(Notice) Foreign Researchers Notice: Translation of Research Materials (Trslt-Ntc) (Effective September 17, 2024)
Research Council of Zimbabwe
(Policy) MCAZ Reliance Policy (ReliancePlcy) (Revision 2) (Effective April 25, 2024)
Medicines Control Authority of Zimbabwe
(Document) List of Language Institutions: A Guide for Foreign Researchers (ZWE-5) (Date Unavailable)
Research Council of Zimbabwe
(Webpage) Criteria for Institution of Affiliation (ZWE-12) (Current as of September 18, 2024)
Research Council of Zimbabwe
(Webpage) Expedited Review for Foreign Researchers’ Applications (ZWE-10) (Current as of September 18, 2024)
Research Council of Zimbabwe
Sources Revised During this Update:
(Guidance) Guidelines for Conducting Good Clinical Practice (GCP) Inspections in Zimbabwe (MCAZ-PVCT-GL-01) (GCP-Inspections) (Revision 1) (Effective May 8, 2024)
Medicines Control Authority of Zimbabwe
(Guidance) Guidelines for Section 75 Applications to Import Unregistered Medicines (Sec75-Imports) (Effective January 12, 2024)
Medicines Control Authority of Zimbabwe
(Form) Application for Additional Investigator(s), Change of Investigator(s), or Additional Clinical Trial Sites (PVF 83) (ZWE-32) (Revision 1) (January 2023)
Medicines Control Authority of Zimbabwe
(Form) Application for a Clinical Trial Protocol Amendment (PVF 82) (ZWE-84) (Revision 1) (January 2023)
Medicines Control Authority of Zimbabwe
(Form) Application to Conduct Research (MRCZ 101) (ZWE-41) (Version 1.8) (May 2024)
Medical Research Council of Zimbabwe
(Form) Application for Continuing Review of Research Activity (MRCZ 102) (ZWE-42) (Version 1.4) (May 27, 2024)
Medical Research Council of Zimbabwe
(Form) Clinical Trial Annual Progress Reporting Form for Investigators (PVF 76) (ZWE-77) (Revision 2) (May 2024)
Medicines Control Authority of Zimbabwe
(Form) Meeting Request Form (PVF 27) (ZWE-37) (Revision 5) (July 2023)
Medicines Control Authority of Zimbabwe
(Form) Recommended Format for CVs of Individuals Participating in Clinical Trials (PVF 78) (ZWE-36) (Revision 1) (January 2023)
Medicines Control Authority of Zimbabwe
(Webpage) Medical Research Council of Zimbabwe – Frequently Asked Questions (ZWE-11) (Current as of September 18, 2024)
Medical Research Council of Zimbabwe