Monday, 21 October 2019
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.
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...
In line with the WHO guidelines on variations and other SRA guidelines, the EVR Division is updating the MCAZ Guidelines for submitting applications for Variations to Registered Medicines. The update...
Background The Medicines Control Authority of Zimbabwe (MCAZ) Regional Centre of Regulatory Excellence (ReCORE) in partnership with the European and Developing Countries Clinical Trials Partnership (EDCTP) is offering...
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...
In this issue: MCAZ turns 20 years Basics of reporting Side Effects of medicines Electronic Adverse Drug Reaction Reporting For more information Please click here to download the Newsletter...
Increased Reporting from the Targeted Spontaneous Reporting (TSR) Programme Click here to download Drug Information Bulletin
Download Complementary medicines applications extension - press statement
The aims of the PV policy handbook are to firstly provide a framework for a national pharmacovigilance system in Zimbabwe. Secondly, to define the pharmacovigilance activities undertaken by the Pharmacovigilance...
The Medicines Control Authority of Zimbabwe (MCAZ) as a responsible corporate citizen runs a Scholarship Fund as part of its corporate social responsibility programmes. Click here to download the...
The approved Guidelines for Advertising and Promotion of Medicines are now available. Download the Guidelines for Advertising and Promotion of Medicines