关键词: 药物警戒, 药品不良反应, 药品不良反应监测, 药品监管, 法律体系

Abstract: Objective To analyze the background and reasons for the establishment of the pharmacovigilance system(PVS) in China, summarize the experience related to the PVS, and provide reference for the development of a new system. Methods Starting with the construction of the legal system, the origin and development of the Adverse Drug Reaction Reporting System (ADRRS) were traced, problems with and new challenges to this system were identified, ways in which the PVS was implemented in the past five years were studied, and tips were given about the implementation of the new system in terms of ideas and range of pharmacovigilance, and system construction. Results The PVS was a natural by-product of the ADRRS, and developed out of the international environment for pharmacovigilance. In the first five years since the implementation of the PVS, the legal system, organizational system, and technical system came to be established and improved, research made steady progress, and the notions of pharmacovigilance took shape. At the same time, new problems emerged. Conclusion The PVS in China is unlikely be an instant success. Strategies involving in-depth research, consideration of all the factors as a whole, step-by-step implementation, and division of labor and cooperation are required. Reform and innovation should be given top priority to promote steady development and constant improvement.

Key words: pharmacovigilance, adverse drug reactions, adverse drug reaction monitoring, drug supervision, legal system