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.
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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