Guideline for Pharmacovigilance Inspection in China

Guideline for Pharmacovigilance Inspection in China has been issued (No.17-2022) by the National Medical Products Administration (NMPA) on April 15, 2022. The Quality Management Practice for Pharmacovigilance has been officially implemented (No.65-2021) since December 1, 2021, and the market authorization holders (MAHs) should have completed information registration in the national adverse drug reaction monitoring system as required. The NMPA regulatory document provides guidance to all provincial drug regulatory departments when carrying out pharmacovigilance inspections, and urges MAHs to implement the main responsibility of pharmacovigilance.

Guideline for Pharmacovigilance Inspection in China – Highlights

The new guideline for pharmacovigilance inspection in China has been reviewed and summarised by our regulatory experts below.

• This regulatory guideline applies to the inspection of the pharmacovigilance activities carried out by MAH or commissioned by MAH by drug regulatory departments.
• For drug registration applicants who are approved to conduct drug clinical trials, the drug regulatory department shall conduct pharmacovigilance inspections based on drug safety characteristics, clinical trial safety information reports and risk assessments, and initiate pharmacovigilance inspections during clinical trials or before marketing authorization.
• This guideline sets out key considerations for routine and for-cause inspections, inspection method, inspection location, evaluation standard and inspection conclusion.
  • Key factors to be considered in routine inspections:
    • Characteristics of drugs
      • The safety characteristics of the drug.
      • Adverse drug reaction monitoring data and the occurrence of adverse drug reaction aggregation events.
      • Drugs with large sales volume or less substitute drugs.
      • Drugs with additional safety conditions when they are approved for marketing.
      • Innovative drugs, improved new drugs, and drugs for special groups such as children and pregnant women.
      • Drugs with high social concern.
    • Characteristics of the holder
      • Holders with more varieties and large sales volume.
      • Holders who have not undergone pharmacovigilance checks.
      • Holders who have obtained a drug registration certificate in China for the first time.
      • Holders who have major changes in the pharmacovigilance system or have a significant impact on the pharmacovigilance organizational structure due to mergers and acquisitions, organizational structure changes, etc.
      • Holder of entrusted production.
      • Holders commissioned to carry out pharmacovigilance activities.
    • Other circumstances
      • Previous pharmacovigilance examination or other examinations.
      • Other situations that the drug regulatory department deems it necessary to carry out inspections.
  • Key factors to be considered in the cause-based inspections:
    • Late reporting, concealment, or omission of suspected adverse drug reaction information, and the reporting quality is poor.
    • Monitoring of adverse drug reactions indicates that there may be safety risks.
    • Failure to discover, assess, control or communicate relevant risks in a timely manner.
    • Suspending production, sales, use and product recall, and failing to report to the drug regulatory authorities as required.
    • Failure to conduct post-marketing safety research, formulate and implement a pharmacovigilance plan as required by regulations or the requirements of drug regulatory authorities, and fail to provide explanations.
    • Failure to provide relevant information on pharmacovigilance as required by drug regulatory authorities or the information provided does not meet the requirements.
    • Delayed implementation or failure to fully implement corrective measures.
    • Other circumstances that require a cause-based inspection.

• The organization and implementation of relevant inspection work shall be in accordance with the relevant requirements such as the “Notice of NMPA on Printing and Distributing the “Administrative Measures for Drug Inspection (Trial)” (No. 31-2021).

The National Medical Products Administration (NMPA) published the following regulatory documents in April 2022 also concerning post-market activities of drug products in China:

• Administrative Measures for Drug Annual Reports (No.16-2022)

Read our separate blog post for more information on the Measures for the Supervision and Administration of Drug Production.

By Yu and Jacky. If you would like to learn more about Pharmacovigilance or our registration and CRO services for pharmaceuticals, medical devices, IVDs, cosmetics, health foods, industrial or consumer goods contact Cisema.