China Pharmacovigilance History

Pharmacovigilance in China: Milestones and Advancements

China pharmacovigilance regulatory reform has a history dating back to 1980’s with the building of ADR monitoring networks in China to more significant evolution after China joined ICH in 2017 which is now the foundation and commitment towards an internationally harmonised PV system. China strengthened pharmacovigilance policies with the introduction of Drug Administration Law in 2019 which set out the framework for developing China Good Pharmacovigilance Practices (GVP) in 2021.
  • 1950 to 1998: Building of ADR monitoring network in China.
  • 1988: Ministry of Health initiates a pilot project on ADR monitoring involving 10 hospitals in China.
  • 1994: 66 hospitals in 26 provinces in China designated as key hospitals for ADR monitoring, marking a significant step towards a comprehensive system.
  • Pre-2017: Regulations and implementation of pharmacovigilance in China not mature nor systematic.
  • September 2018: China NMPA releases Announcement No. 66 mandating MAHs to report ADRs through NADRMS based on the principle of reporting on suspicion in CHina.
  • 2019: China Drug Administration Law released, requiring pharmaceutical companies to establish pharmacovigilance and annual reporting systems in China.
  • 2020: China GCP revised with the release of the fourth edition by NMPA and NHC.
  • May 2021: China GVP 2021 is officially released and comes into force on December 1st, marking a new chapter for PV in China.
  • 2022: Official China guidance document on writing pharmacovigilance systems is published, further standardizing the framework and reducing the difficulty of building PV systems.

China PV Policy Trend

In the near to medium term, the Chinese authorities is expected to continue to accelerate and enforce GVP and pharmacovifilance regulations to improve drug safety and patient outcomes.
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