GVP requires drug marketing authorization holders (MAHs) and drug registration applicants to establish and improve pharmacovigilance (PV) systems as well as conduct pharmacovigilance activities compliantly. Pharmacovigilance activities are subject to national and provincial medical products’ inspections according to the Pharmacovigilance Inspection Guidelines.

To help pharmaceutical companies with PV compliance in China, this article introduces:

1. GVP Application Scope

2. China GVP Contents

3. Pharmacovigilance for MAHs

• 3.1 Pharmacovigilance System Quality Management
• 3.2 Pharmacovigilance System Master File
• 3.3 Individual Case Safety Report
• 3.4 Post-market Safety Study
• 3.5 Periodic Safety Update Report
• 3.6 Risk Management

4. Pharmacovigilance for Drug Applicants

1. GVP Application Scope

The Chinese GVP applies to pharmacovigilance activities of

1.   Drug marketing authorization holders (MAHs); and
2. drug registration applicants approved to carry out clinical trials.

Pharmacovigilance activities refer to activities to monitor, identify, evaluate, and control adverse drug reactions (ADRs) and/or other negative reactions related to medication.

2. China GVP Contents

China’s GVP contains 9 chapters, with 134 articles under 21 sections. Following Chapter 1 General Principles, Chapter 2-7 are mainly for MAHs, while Chapter 8 focuses on PV for drug registration applicants during clinical trials.

3. Pharmacovigilance for MAHs

3.1 Pharmacovigilance System Quality Management

MAHs shall establish the pharmacovigilance system that includes organization, personnel, rules & procedures, resources, and other pharmacovigilance-related elements. The system should be adapted to MAH’s type, size, the number of held drugs, safety characteristics, etc.

MAHs shall manage the quality of pharmacovigilance system and related activities, and incorporate the critical pharmacovigilance activities into the quality assurance system. The following points should be paid attention to:

1. Setting up a properly structured organization;
2. Arranging qualified personnel, equipment, and resources for pharmacovigilance activities;
3. Establishing a management system in compliance with laws and regulations;
4. Establishing procedures that are comprehensive, clear, and operable;
5. Establishing effective and open channels for collecting information on suspected adverse drug reactions;
6. Reporting and handling the aforementioned information in compliant with laws and regulations;
7. Effectively identifying and evaluating risk signals;
8. Effectively controlling the identified risks;
9. Ensuring pharmacovigilance documents and records are available, checkable, and traceable.

MAHs shall make and update pharmacovigilance quality control goals which include but are not limited to:

1. the compliance of adverse drug reaction (ADR) report;
2. the compliance of periodic safety update report (PSUR);
3. the timeliness of signal detection and evaluation;
4. the timeliness of updating the pharmacovigilance system master file (PSMF);
5. the formulation and implementation of the pharmacovigilance plan;
6. the formulation and implementation of the personnel training plan.

Furthermore, MAHs shall conduct internal audit of the pharmacovigilance system periodically and take corrective and preventive actions (CAPA) for the issues found in the audit.

Pharmacovigilance work is permitted to be entrusted to a third party. The entrusted party should be a legal corporate entity in China and capable of ensuring effective pharmacovigilance operation. Despite entrustment, MAHs remain as the responsible subjects for pharmacovigilance and shall assume relevant legal obligations.

3.2 Pharmacovigilance System Master File (PSMF)

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