Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. The concept of pharmacovigilance is borne out of the recognition that no medicine is completely risk-free.
The specific aims of pharmacovigilance are to:
Source: The Importance of Pharmacovigilance, WHO 2002
MCAZ houses the National Pharmacovigilance Centre which participates in the WHO Programme for International Drug Monitoring
The Authority wishes to notify stakeholders of the addition of several new methods of submitting Adverse Drug Reaction (ADR) reports, Serious Adverse Events (SAE) reports for clinical trials, Adverse Events Following Immunisation (AEFI) reports and SAE reports from pharmaceutical industry I E2B format.
The new methods include use of the Android Mobile App, Apple iOs Mobile App, Windows Desktop App, MacOs Desktop App, Linux Desktop App, as well as the Browser-Based Web App. These can be accessed from the respective links on this page.
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