Monitoring of adverse drug reactions (ADR) including collection, evaluation and management of ADR data.
Monitoring of other medicine-related safety issues including collection, evaluation and management of information related to quality, lack of efficacy, and counterfeiting of medicines.
Maintaining the national database of adverse drug reactions
Expertise of risk management plan (RMP) and managing the risk minimization measures.
Expertise and confirmation of publishing information related to safety of medicines.
Expertise of periodic safety update reports (PSUR)
Signal detection and management
Expertise of post-registration safety variations.
Provision of safety report for regulatory decisions
Provision ofsafety communication
Development of educational and training materials to raise awareness on medicine safety
Publishing “Safety of medicines” bulletin
Screening of literature and other sources on medicine safety
Accepting public inquiries on ADRs and medicine-related other safety issues and providing feedbacks byhot-line route