Tuesday, 15 June 2021
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.
Details of approved, ongoing and previously approved clinical trials will be made available on this site in due course.
Medicines Review
During the process of medicine registration and post registration the MCAZ is engaged in the process of reviewing the acceptability of certain Active Pharmaceutical Ingredients (API), Combinations of APIs and excipients for use in medicinal products.
Information on current policies and guidelines will be made available soon.
The Quality Policy of the Medicines Control Authority of Zimbabwe (MCAZ) is to ensure the provision of accurate and timeous services, continuously meet requirements of our customers and guarantee patient...
Guidance on submission of covid-19 vaccine applications for emergency use authorisation and registration have been published. Click MCAZ COVID-19 VACCINE GUIDANCE-VERSION 11 download the guideline.
In order to improve service delivery to our valued customers, MCAZ collects information on Customer Complaints. To download the 2019 Customer Complaints Trends Analysis Click here
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The draft Blood and Blood Components Regulations are now available Please note that this is a DRAFT that has been uploaded to obtain comments from stakeholders before the regulations are...
This Medical Product Alert warns consumers, healthcare professionals, and health authorities against a growing number of falsified medical products that claim to prevent, detect, treat orcure COVID-19. Medical...
Draft SADC Variations Guidelines are now available Click the following links to download the guidelines and the comments sheet Draft SADC Variations Guidelines Draft SADC Variations Guidelines Comments Sheet
In pursuit of promoting high ethical standards, the Authority has formulated a Code of Ethics for its employees and members of the Authority .The Authority believes that high ethical...
Southern African Development Community (SADC), as a region has harmonized medicines registration guidelines in the common technical document (CTD) format that were approved in January 2015. Nevertheless, the harmonization...