Tuesday, 28 January 2020
Activities of the Pharmacovigilance & Clinical Trials are:
*To approve and monitor all clinical trials medicines and medical devices that are conducted in Zimbabwe in terms of Part III of the Medicines and Allied Substances Control Act of 1991 [Chapter 15:03].
*To deal with medicine's post-registration issues. This means that after medicines have been registered by the Authority, any issues to do with the review of those medicines fall under this unit, including the processing of applications for amendments for registered medicines.
*To approve and monitor all clinical trials involving medicines and medical devices that are conducted in Zimbabwe in terms of Part III of the Medicines and Allied Substances Control Act of 1991 [Chapter 15:03]
*To conduct Pharmacovigilance activities which include: post-market surveillance of registered medicines; collecting and analysing Adverse Drug reports;
*Drug information dissemination through publishing a quarterly drug information bulletin.
Inside this issue: E-Reporting Tools Safety Notifications for Fluoroquinolones and Quinolones Antibiotics Notification of a potential risk of non-melanoma skin cancer (basal cell carcinoma, squamous cell carcinoma) in patients treated...
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 the 2018 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