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Pharmacovigilance in China: A review
  • +6
  • Haibo Song,
  • Xiaojing Pei,
  • Zuoxiang Liu,
  • Chuanyong Shen,
  • Jun Sun,
  • Yuqin Liu,
  • Lingyun Zhou,
  • Sun Feng,
  • Xiaohe Xiao
Haibo Song

Corresponding Author:[email protected]

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Xiaojing Pei
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Zuoxiang Liu
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Chuanyong Shen
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Lingyun Zhou
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Sun Feng
Peking University Health Science Center
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Xiaohe Xiao
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Drug-related adverse reactions are among the main reasons for harm to patients under care worldwide and even their deaths. The pharmacovigilance system has been proven to be an effective method of avoiding or alleviating such adverse events. In 2019, after two decades of implementation of the drug-related adverse reaction reporting system, China formally implemented a pharmacovigilance system with the Pharmacovigilance Quality Management Standards and a series of supporting technical documents created to improve the safety of medication given to patients. China’s pharmacovigilance system has faced many problems and challenges during its implementation. This spontaneous reporting system is the main source of data for China’s medication vigilance activities, but it has not provided sufficiently powerful evidence for regulatory decision-making. In conformity to the health-centered drug regulatory concept, the Chinese government has accelerated the speed of examination and approval of urgently needed clinical drugs and orphan drugs along with the requirement to improve the safety supervision of these drugs after their listing. China’s marketing authorization holders(MAHs)must strengthen its pharmacovigilance capabilities as the primary responsible department for drug safety. Chinese medical schools generally lack professional courses on pharmacovigilance. The regulatory authorities have recognized such problems and have made efforts to improve the professional capacity of pharmacovigilance personnel and to strengthen cooperation with stakeholders through the implementation of an action plan of medication surveillance and the establishment of patient-based adverse events reporting system and active surveillance systems, which will help China bridge the gap to bring its pharmacovigilance practice up to standards.
14 Oct 2021Submitted to British Journal of Clinical Pharmacology
18 Oct 2021Submission Checks Completed
18 Oct 2021Assigned to Editor
21 Oct 2021Reviewer(s) Assigned
06 Dec 2021Review(s) Completed, Editorial Evaluation Pending
21 Dec 2021Editorial Decision: Revise Minor
11 Jan 20221st Revision Received
17 Jan 2022Submission Checks Completed
17 Jan 2022Assigned to Editor
17 Jan 2022Review(s) Completed, Editorial Evaluation Pending
02 Feb 2022Editorial Decision: Accept