Good Pharmacovigilance Practices (GVP) was officially released in May 2021 and entered into force since December 1st, 2021, opening a new chapter for Pharmacovigilance in China.
BaiPharm delivers end-to-end China pharmacovigilance (GVP) compliance support — covering ICSR monitoring, literature screening, PSUR/PBRER preparation, RMP development, PSMF maintenance, RPPV/QPPV services, and SUSAR/DSUR reporting — helping overseas MAHs establish and operate a compliant, sustainable drug safety system in China.
Regulatory Context
Good Pharmacovigilance Practices (GVP) was officially released in May 2021 and entered into force since December 1st, 2021, opening a new chapter for Pharmacovigilance in China.
Competent Authority
Center for Drug Evaluation of NMPA (CDE) → For Clinical PV
Center for Drug Reevaluation of NMPA (CDR)/National Center for ADR Monitoring → For Post Marketing PV
Post Marketing PV
Quality Management System
Companies shall establish and maintain a robust pharmacovigilance (PV) quality system, including a dedicated PV department, the appointment of a Responsible Person for Pharmacovigilance (RPPV/QPPV), a Drug Safety Committee (DSC), standardized SOPs, a management system for outsourced PV activities, and periodic internal audit mechanisms.
Individual Case Safety Report (ICSR) Monitoring and Management
A valid ICSR must contain the following four minimum criteria: an identifiable patient, an identifiable reporter, a suspected medicinal product, and a suspected adverse reaction.
We provide comprehensive ICSR management services in compliance with China's pharmacovigilance regulations, including:
Monitoring, assessment, case processing, quality review, and regulatory submission of ICSRs
Submission of non-serious adverse drug reactions (ADRs) within 30 days of initial receipt
Expedited reporting of serious ADRs within 15 calendar days from the date the MAH first becomes aware of the case
Screening, evaluation, processing, and reporting of literature-derived ADR cases associated with the MAH's products
Assessment and documentation of cases with uncertain causality in the PSUR, as appropriate
Submit overseas serious ADRs and ADRs arising from relevant drug-related studies or data collection programs as ICSRs.
Literature Screening
Literature screening is conducted at frequencies mutually agreed upon with the client and in compliance with applicable regulatory requirements. To ensure comprehensive literature surveillance, searches are performed using at least two Chinese databases (e.g., CNKI, VIP, and Wanfang) and two international databases (e.g., PubMed, Embase, and Ovid).
Periodic Safety Update Report (PSUR)
The PSUR should include complete and continuous safety information covering the entire reporting period, starting from the China Birth Date (CBD) or International Birth Date (IBD), as applicable.
For innovative drugs and modified new drugs, PSURs shall be submitted annually from the date of marketing approval until the first license renewal, and subsequently every five years thereafter. For other categories of drug products, PSUR submission is generally required every five years from the date of marketing approval.
PSURs shall be reviewed and approved by the RPPV or QPPV. Where acceptable to the relevant regulatory authority, a Periodic Benefit-Risk Evaluation Report (PBRER) may be submitted in lieu of a PSUR.
Active pharmaceutical ingredients (APIs), in vitro diagnostic reagents, Chinese medicinal materials, and traditional Chinese medicine decoction pieces are exempt from PSUR reporting requirements.
Pharmacovigilance System Master File (PSMF)
The PSMF provides a comprehensive and systematic description of the structure and operation of the corporate pharmacovigilance system, ensuring transparency, compliance, and effective oversight of PV activities.
It typically includes the following key components:
Organization: PV-related organizational structure, responsibilities, and reporting relationships, etc.
RPPV/QPPV basic information, including region of residence, contact information, CV, responsibilities, etc.
Specialized personnel status, including number of personnel, relevant qualifications/background, responsibilities, etc.
Sources of suspected ADRs, including major collection channels, collection methods, etc.
Introduction to information tools/systems
Management policies and SOPs
Pharmacovigilance system operation description
Introduction to PV outsourcing/entrustment arrangements
Quality management
Annexes, including the PV system and SOPs, drug product list, entrustment agreements, internal audit reports, PSMF revision log, etc.
Clinical PV
SUSAR
Suspected Unexpected Serious Adverse Reactions (SUSARs) are submitted through the regulatory gateway in E2B (R3) electronic format.
Fatal or life-threatening SUSARs: shall be reported ASAP within 7 days of awareness, with a follow-up report submitted within 8 days after the initial report.
Other SUSARs: shall be reported ASAP within 15 days of awareness, with follow-up reports submitted within 15 days after receipt of new information.
DSUR
The reporting period starts from the Development International Birth Date (DIBD). The first DSUR shall be submitted within 2 months following the first International Birth Date (IBD) after Clinical Trial Application (CTA) approval in China.
Our Services
Case Reporting (ICSRs): Processing, Quality Control and Submission of Post-marketing ICSRs
Literature Screening
Signal Monitoring and Risk Assessment
China RPPV/QPPV Support
Periodic Safety Update Reports (PSURs)
China Risk Management Plan (RMP)/Pharmacovigilance Plan
PV Annual Report
PV System Master File (PSMF)
Competent Authority Inspection and Audit Support
Training and Business Partner Oversight
SUSAR Reporting and DSUR Preparation (for Clinical PV)
Why Choose BaiPharm?
BaiPharm, a specialized subsidiary of REACH24H Consulting Group, is dedicated to pharmaceutical regulatory compliance. With offices in the U.S., EU, Japan, and South Korea, our expert team—including regulatory specialists, GxP auditors, consultants, certified toxicologists, and former inspectors—has supported over 600 pharmaceutical firms from 26 countries. We provide full-process Domestic Responsible Person (DRP) services and integrated global solutions for Pharmaceutical Intermediates, APIs, Excipients, Packaging Materials, Drug Products, and Medical Devices. Our offerings include Product Registration, Pharmacovigilance (PV), GxP Compliance, Regulatory Intelligence & Consulting, and Toxicological Risk Assessment, ensuring compliant, efficient, and reliable market entry.
We have extensive hands-on experience in full-lifecycle China pharmacovigilance (PV) compliance management in China and have successfully supported multiple PV outsourcing projects for international MNCs. Our capabilities cover the entire PV value chain, including clinical-stage safety management (SUSAR reporting and DSUR preparation), post-marketing PV activities (ICSR processing, literature surveillance, PSUR/PBRER preparation), and pharmacovigilance system establishment (including PSMF development and maintenance).
With a thorough understanding of China's GVP requirements and NMPA/CDE regulatory expectations, we help clients effectively identify and manage compliance risks, support timely regulatory submissions, minimize the risk of regulatory findings, and ensure the delivery of high-quality pharmacovigilance outputs.
We provide end-to-end PV compliance solutions, enabling global clients to establish and maintain robust, sustainable, and compliant drug safety operations in China.
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