Pharmacovigilance Audit and Inspections in China

Internal Audit

Pharmacovigilance audit is a vital process that reviews the drug safety system to ensure it meets regulations, guidelines, and standard operating procedures. It involves internal or external auditors who are independent of the system. Internal auditors, part of the safety or quality assurance team, conduct periodic reviews, while external auditors provide an objective assessment.
The audit evaluates various aspects, including the organizational structure, standard procedures, safety database, signal detection, risk management, and adverse event reporting. It assesses data quality, identifies system gaps, and provides recommendations for improvement.
Compliance with regulations and guidelines is a key focus of pharmacovigilance audits. The audit team ensures adherence to Good Pharmacovigilance Practice (GVP) and International Council for Harmonization (ICH) guidelines, ultimately enhancing drug safety. China GVP also described the audit requirement1:
Chapter II Quality Management Section 2 Internal Audits
Article 11 Holders shall conduct periodic internal audits (hereinafter referred to as “internal audits”) to review various systems, procedures, and their implementation status, and to assess the suitability, adequacy, and effectiveness of the pharmacovigilance system. When any significant changes occur to the pharmacovigilance system, internal audits should be carried out in a timely manner. The internal audit can be carried out independently, systematically, and comprehensively by the holder’s designated personnel, or by external personnel or experts.
Article 12 An audit plan shall be developed before the internal audit. The plan should include internal audit objectives, scope, methods, standards, auditors, audit records and reporting requirements, etc… While developing the plan, key pharmacovigilance activities, key positions, and previous audit results, etc. should be considered.
Article 13 Records shall be kept for internal audits, including the basic information, content and results of the audit, and a written report shall be formed.
Article 14 For the findings identified in the internal audit, holders shall investigate the root cause and take corresponding corrective and preventive actions. The corrective and preventive actions should be followed-up and assessed.
Reference: 1. China Good Pharmacovigilance Practice Announcement of the NMPA on the Publication of China Good Pharmacovigilance Practice (No. 65 of 2021)
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Regulatory Inspections

The overarching authority responsible for drug and pharmacovigilance inspections is China’s National Medical Products Administrations (NMPA). The pharmacovigilance audit and inspection work are conducted in groups formed by the Drug Inspection Institutions. The complete inspection is fulfilled with the support of the following four institutions:
  • Drug Testing Institutions
  • Centre for Drug Evaluation (CDE)
  • Centre for Drug Reevaluation (CDR)
  • National Centre for ADR Monitoring.
In addition, the legal departments will be involved upon legal issues.

Authority for Supervision of Drugs

  • NMPA and Local MPA including Provincial, Municipal, and County level are responsible to set up and designate pharmaceutical and pharmacovigilance inspection institutions in accordance with law.
  • NMPA shall be responsible for forming annual supervision and inspection plan, arranging inspection tasks, or organizing inspections, and work according to the Report on Comprehensive Evaluation of Drug Inspection and relevant evidence materials.
  • NMPA shall set up a professional team of specialized drug inspectors, implement multi-level & classification system for inspectors, formulate the standards of duties and duties of inspectors at different levels as well as requirements for comprehensive capability, and establish strict criteria for relevant positions.
  • NMPA and the drug inspection institution is responsible for establishing inspector database and inspector information platform to realize the information sharing and coordination of inspectors at all levels from national to county-level.

Institutions for Drug Inspection

  • Drug inspection institutions carry out inspections according to China’s laws and regulations on drug supervision before issuing the Comprehensive Evaluation Report on Drug Inspection and be responsible for daily management of professional inspector team and implementation of inspection plans and tasks.
  • Other departments such as drug inspection, review, evaluation, and adverse drug reaction (ADR) monitoring established shall provide technical support during the inspection.
  • Drug inspection institutions shall establish a quality management system to continuously improve the quality of drug inspection work.
  • The drug supervision authority or drug inspection institution is responsible for establishing inspector database and inspector information platform to promote the information sharing and coordination of inspection within national, provincial, and county levels.

Drug Inspection Group

  • The inspection group should be set up by the pharmacovigilance inspection team to carry out the audit.
  • Usually, an inspection group consists of more than 2 qualified inspectors
  • The team leader is responsible for the inspection team. When necessary, experts in relevant fields can be selected to participate in the inspection

Authority Inspection Key Points

According to Guidelines for Pharmacovigilance Inspections1 released by the NMPA, a total of 100 checking items are listed. 12 of which are critical and 40 are major points.
This is the 5 key points for authority inspection.
  • Institution, personnel and resources, refers to 22 articles from GVP
  • Quality management, documentation and record, refers to 28 articles
  • Monitor and report, refers to 17 articles.
  • Risk identification and evaluation, refers to 19 articles.
  • Risk control, refers to 14 articles.
Throughout the first year of 2022, the authorities overseeing drug testing, review, evaluation, and adverse drug reaction (ADR) monitoring focused their attention primarily on the first two points. These areas were given priority due to their direct accessibility and evaluative nature. In addition, the authorities made efforts to understand the operational practices within pharmaceutical companies. As we enter 2023, inspection groups have gained valuable experience, which will be reflected in their increased emphasis on activities such as signal detection, reporting, and risk control, among others.
The following is part of Pharmacovigilance Inspection Check Points in the official Guidelines for Pharmacovigilance Inspections.
For full PDF (original Chinese and English translated version) of Guidelines for Pharmacovigilance Inspections and the Annex – Pharmacovigilance Inspection Check Points Table, please contact us via online chat or email.
Reference: 1. Guidelines for Pharmacovigilance Inspections, Announcement by the NMPA on the issuance of the Guidelines for Pharmacovigilance Inspections No. [2022] 17
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