PROTECTING YOUR RIGHT TO MEDICINES AND MEDICAL DEVICES
Tuesday, 15 October 2019

The Authority wishes to notify stakeholders of the introduction of the MCAZ electronic Clinical Trials application and registry system (e-CTR System).

This system allows investigators to submit applications for authorisation of clinical trials to MCAZ, to view the progress of the applications in real-time and to respond to queries raised. This system can be accessed using the link below:

e-Clinical Trials Submission

 

After the clinical trial has been authorised, the system also allows investigators to submit SAE reports, protocol amendments, protocol deviations, progress reports and any other notifications or post-authorisation applications to MCAZ. The list of clinical trials authorisation by MCAZ from August 2019 onwards can be viewed using the link provided below:

Publicc Clinical Trials Registry

 

Clinical trials are defined as a systematic study in human beings or animals inorder to establish the efficacy of, or to discover or verify the effects or adverse reactions of medicines, and includes a study of the absorption, distribution, metabolism and excretion of medicines.

All clinical trials that are conducted in Zimbabwe are regulated in terms of Part III of the Medicines and Allied Substances Control Act [Chapter 15:03] and its regulations. In terms of the Act, no person shall conduct a clinical trial of any medicine without the prior written authorisation of the Authority, granted with the approval of the Secretary of the Ministry of Health and Child Welfare.

The guidelines for Good Clinical Practice have been updated. You will find the new guidelines on the Downloads page. The file is entitled "Guidelines for GCP 2012 Zimbabwe", it replaces "Zimbabwe Guidelines for good clinical trial practice", which has been removed from this website.
 

 

 

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