Pharmacovigilance is a scientific research and activity related to the discovery, evaluation, understanding and prevention of adverse reactions or any other problems that may be related to drugs. Pharmacovigilance involves not only adverse drug reactions, but also other drug-related problems, such as substandard drugs, drug treatment errors, reports of lack of effectiveness, drug use for indications without sufficient scientific basis, case reports of acute and chronic poisoning, drug-related mortality assessment, drug abuse and misuse, and adverse interactions between drugs and chemicals, other drugs and food.
legal ground
"Pharmacovigilance Quality Management Standard" Article 1 In order to standardize the pharmacovigilance activities in the whole life cycle of drugs, this standard is formulated in accordance with the relevant provisions of the Drug Administration Law of People's Republic of China (PRC) and the Vaccine Administration Law of People's Republic of China (PRC). Article 6 The pharmacovigilance system includes institutions, personnel, systems, resources and other elements related to pharmacovigilance activities, which should be adapted to the types, scales, quantities of the varieties held and the safety characteristics of the holders.