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No clinical trial of a medicine involving human participants may begin in Zimbabwe until the Medicines Control Authority of Zimbabwe (MCAZ) has authorized it, with the concurrence of the Secretary for Health and Child Welfare. MCAZ’s Pharmacovigilance and Clinical Trials (PVCT) Division runs this authorization through an online system, and it works alongside — not instead of — ethics review from the Medical Research Council of Zimbabwe (MRCZ). This guide covers the legal basis, the application itself, review timelines, and what happens after authorization.
Legal Basis
Clinical trial regulation in Zimbabwe rests on two instruments: the Medicines and Allied Substances Control Act (MASCA), Chapter 15:03, which establishes MCAZ’s general regulatory authority over medicines and related products, and Statutory Instrument 150 of 1991, which sets out the detailed regulations governing how clinical trials are conducted. Together they require that “all clinical trials of medicines in Zimbabwe involving human participants must not be initiated until the MCAZ has, with the approval of the Secretary for Health and Child Welfare, authorised the conduct of the trial” — authorization is a precondition for starting a trial, not a formality completed alongside it.
Who Authorizes Clinical Trials in Zimbabwe
MCAZ’s Clinical Trial Unit, within its Pharmacovigilance and Clinical Trials Division, receives, processes, and evaluates applications to conduct clinical trials from industry sponsors, academic researchers, and independent investigators, and separately authorizes the importation of unregistered investigational medicines for trial purposes. Ethical review runs through the Medical Research Council of Zimbabwe (MRCZ), which collaborates with MCAZ on trial oversight, including joint serious adverse event (SAE) reporting protocols. As with peer regulators across the region, MCAZ’s regulatory authorization and MRCZ’s ethical approval are both required and neither substitutes for the other.
The MC10 Application Process
Sponsors apply using Clinical Trial Application Form MC10, submitted online through MCAZ’s e-CTR system (e-ctr.mcaz.co.zw), together with the prescribed fee. A complete submission includes:
- Clinical Trial Application Form MC10
- A completeness checklist confirming the application meets MCAZ’s documentation requirements
- A submission declaration by the applicant
- CVs for the investigator(s) in MCAZ’s recommended format
- A joint declaration by sponsor and principal investigator confirming sufficient funding for the trial
- GCP compliance declarations from the principal investigator, co-investigators, and sub-investigators
- An indemnity form covering trial participants
- Enrollment on MCAZ’s clinical trial registry platform
Once a trial is underway, MCAZ’s e-CTR system also handles protocol amendment applications, additional-investigator or site-change applications, annual progress reports, and SAE reports filed jointly to MCAZ and MRCZ.
Review Timelines
MCAZ’s published guidance for its PVCT Division sets a standard review-and-approval timeline of up to 60 working days from receipt of a complete application, excluding any “clock stops” while the applicant addresses queries MCAZ raises during review. For trials tied to emergency preparedness, MCAZ’s guidance allows for an expedited timeline of 15–30 working days, conditional on the sponsor submitting a complete application early. Sponsors should treat the standard 60-working-day figure as the planning baseline and confirm current timelines directly with MCAZ, since regulators in this position revise process guidance more often than they revise the underlying statutory instrument.
Ongoing Oversight and Amendments
Any amendment to an authorized trial — protocol changes, additional sites, additional investigators — requires MCAZ approval before it takes effect; sponsors cannot implement a change and notify MCAZ after the fact. MCAZ’s current Good Clinical Practice guidance (Guidelines for Good Clinical Trial Practice in Zimbabwe) and its clinical trial guideline circulars are periodically revised, most recently reflected in versions dated through 2024–2025 at the time of writing; sponsors should confirm they are working from MCAZ’s current published edition.
Zimbabwe in Context: Comparing MCAZ to Peer African Regulators
Zimbabwe’s MCAZ sits alongside a growing set of African national regulators with formal clinical-trial-authorization pathways, including South Africa’s SAHPRA, Ghana’s FDA, Nigeria’s NAFDAC, and Kenya’s Pharmacy and Poisons Board. What distinguishes MCAZ’s process in practice is its fully online e-CTR submission system and its explicit, published dual-timeline structure (60 working days standard, 15–30 expedited for emergency-preparedness trials) — a level of published process specificity not every peer regulator in the region makes public. For trials spanning multiple African jurisdictions, see this site’s guide to the African Medicines Agency and its emerging multi-country review pathway.
Frequently Asked Questions
What form do I submit to apply for clinical trial authorization in Zimbabwe?
Clinical Trial Application Form MC10, submitted online through MCAZ’s e-CTR system (e-ctr.mcaz.co.zw), together with the completeness checklist, supporting declarations, and the prescribed fee.
Does MCAZ authorization replace ethics committee approval?
No. MCAZ’s regulatory authorization and ethical review by the Medical Research Council of Zimbabwe (MRCZ) are both required. MCAZ and MRCZ collaborate directly on trial oversight, including joint serious adverse event reporting.
How long does MCAZ take to review a clinical trial application?
MCAZ’s guidance sets a standard timeline of up to 60 working days from receipt of a complete application, excluding time the applicant spends addressing queries. Emergency-preparedness trials can qualify for an expedited 15–30 working day timeline if a complete application is submitted early.
Can MCAZ authorize the import of an unregistered investigational medicine?
Yes. MCAZ’s Clinical Trial Unit separately authorizes the importation of unregistered medicines specifically for the purpose of conducting an authorized clinical trial.
Sources
Medicines Control Authority of Zimbabwe (MCAZ) — its Clinical Trials page, published Guidelines for Good Clinical Trial Practice in Zimbabwe (MCAZ/PVCT/GL-05), and its 2022 Revised Clinical Trial Guidelines circular; PharmaRegulatory.in’s country-specific overview of MCAZ; and NIAID’s ClinRegs country-regulatory-profile updates for Zimbabwe. Sponsors should confirm current fees, the latest guideline edition, and any recent process changes directly with MCAZ before submitting an application.
