Malaysian Guidelines for the Reporting & Monitoring
These guidelines have been developed to outline the requirements and procedures to be followed for submission of reports of adverse drug reactions to the Drug Control Authority (DCA).
Under current arrangements, the National Adverse Drug Monitoring Centre and the Malaysian Adverse Drug Reactions Advisory Committee (MADRAC) Secretariat are located within the National Pharmaceutical Control Bureau, which in turn acts as the Secretariat to the DCA.
Although these guidelines and certain stipulations are not obligatory, registration holders and health professionals are encouraged to comply in the spirit of cooperation towards establishing the safety profile of drugs which may be under evaluation as well as for products already registered by the DCA.
The DCA hopes that the recommendations in this document will help to improve the quality and standard of safety monitoring of products used in Malaysia.
CHE MOHD ZIN CHE AWANG
DIRECTOR, PHARMACEUTICAL SERVICES DIVISION and CHAIRMAN
MALAYSIAN ADVERSE DRUG REACTIONS ADVISORY COMMITTEE
MINISTRY OF HEALTH MALAYSIA, KUALA LUMPUR, MARCH 2002
The Malaysian Adverse Drug Reactions Advisory Committee