title: Pharmacovigilance in China: current situation, successes and challenges.
abstract: With the integration of the global pharmaceutical economy and the gradual transformation of the healthcare insurance system in China, the legislative framework for a comprehensive regulatory system monitoring the whole process including drug development, manufacture, distribution and use has been established by the China Food and Drug Administration (CFDA) to ensure the safety and effectiveness of medication use. China has established a relatively comprehensive pharmacovigilance system covering regulation, organisation and technology from 1989 to 2014. As of 2013, one national centre, 34 provincial centres and more than 400 municipal centres for adverse drug reaction (ADR) monitoring were included in the four-level pharmacovigilance network (national, provincial, municipal and county) with more than 200,000 grassroot organisation users. The China Adverse Drug Reaction Monitoring System (CADRMS) is an online spontaneous reporting system which connects the four-level pharmacovigilance network. By 2013, CADRMS had received over 6.6 million ADR case reports. After integrating and analysing pharmacovigilance data, the National Centre for ADR Monitoring (NCADRM) publishes medication safety information by releasing ADR bulletins, National ADR Annual Reports and International Pharmacovigilance Newsletters. The NCADRM also routinely provides CADRMS data feedback to manufacturers. The CFDA implemented risk management through several approaches, including arranging 'manufacturer communication meetings', modification of medication package inserts, and restriction, suspension or withdrawal of marketing authorisations. Seamless information exchange with overseas regulatory authorities and organisations remains an area for improvement. Further development of the China pharmacovigilance system in terms of signal generation, post-marketing pharmacoepidemiology research and education is also needed.
authors.affiliation: Center for Drug Reevaluation, China Food and Drug Administration, Beijing, China.
authors.forename: Li
authors.initials: L
authors.lastname: Zhang
authors.forename: Lisa Y L
authors.initials: LY
authors.lastname: Wong
authors.forename: Ying
authors.initials: Y
authors.lastname: He
authors.forename: Ian C K
authors.initials: IC
authors.lastname: Wong
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D002681:China; D004335:Drug and Narcotic Control / Q000458:organization & administration; D006801:Humans; D060735:Pharmacovigilance; D011358:Product Surveillance, Postmarketing; D012308:Risk Management / Q000458:organization & administration