Pharmacovigilance (PV) in China refers to the scientific and regulatory activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The objective is to ensure drug safety throughout the product’s lifecycle, from clinical development to post-marketing use.
In recent years, China has significantly strengthened its pharmacovigilance system to align with international standards, following major reforms in its Drug Administration Law (DAL, 2019) and the issuance of the Good Pharmacovigilance Practice (GVP) guidelines by the National Medical Products Administration (NMPA) in 2021.
Key Legal & Regulatory Basis
- Drug Administration Law (2019 revision)
- Establishes the legal requirement for a PV system in China: monitoring, identifying, evaluating and controlling adverse drug reactions (ADRs) and other harmful reactions.
- Vaccine Administration Law
- Also provides basis for PV obligations in vaccines.
- National Medical Products Administration (NMPA) Good Pharmacovigilance Practices (GVP)
- Issued May 13, 2021, effective Dec 1, 2021.
- Also called “Pharmacovigilance Quality Management Specifications.”
- Provincial/Local Guidelines
Who is Subject to These Requirements
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- Marketing Authorization Holders (MAHs) of medicinal products.
- Drug registration applicants who have been approved to conduct clinical trials.
Even if activities are contracted out to a third party, the MAH remains ultimately responsible. The entrusted party must be a legal entity in China.
System & Organizational Requirements
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- MAHs must establish a PV department, or otherwise ensure structure to support PV activities, including a Drug Safety Committee.
- There must be personnel with responsibilities for PV; “in‐charge” persons must have relevant background, experience (often > 3 years), knowledge of regulations.
- Adequate resources: facilities (tools, systems), training, documentation.
Reporting Requirements
- Periodic Safety Update Reports (PSURs)
- For innovative or “improved new” drugs: annually after marketing approval
- For other (non-innovative) drugs: every 5 years.
- Adverse Reaction Reporting (ICSR-type)
- Suspected ADRs must be reported via electronic system to NMPA.
- Reporting includes both those occurring in China and overseas for products marketed in China.
Risk Management & Risk Control
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- Risk signal detection, risk assessment, risk control measures are required.
- Risk control may include label changes, updating the instructions for use, changing packaging/specifications, etc.
- There is a requirement for a Pharmacovigilance Plan as part of risk management.
Documentation & Records
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- Pharmacovigilance System Master File (PSMF) required. It must be maintained and updated. This includes structure, procedures, personnel, data sources, etc.
- Internal audit, quality management procedures.
- Documentation of all PV-related standard operating procedures, data, record keeping.
Compliance & Enforcement
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- Inspections by national and provincial medical products administrations.
- Violations (e.g. failure to report) can lead to administrative warnings, orders to rectify, fines (for MAHs) and even suspension of business.
Key Takeaways
China’s PV system is based on the Drug Administration Law (2019) and Good Pharmacovigilance Practices (GVP, 2021) under the NMPA.
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- Marketing Authorization Holders (MAHs) are fully responsible for drug safety, even when outsourcing PV activities.
- MAHs must have a PV system, a qualified responsible person, and sufficient resources for monitoring and reporting.
- ADR reports must be submitted electronically, and PSURs filed regularly (annually or every 5 years).
- Continuous risk management, signal detection, and maintenance of a Pharmacovigilance System Master File (PSMF) are mandatory.
- The NMPA conducts inspections, and non-compliance can lead to warnings, fines, or suspension of authorization.
Authored By : Hassene Mokaadi
Senior Project Manager, Baupharma.
