Introduction
As China strengthens its regulatory framework for drug safety, the implementation of the Good Pharmacovigilance Practice (GVP) guidelines plays a crucial role in ensuring the safety and efficacy of pharmaceutical products throughout their lifecycle. These guidelines, introduced by the National Medical Products Administration (NMPA), set clear requirements for Marketing Authorization Holders (MAH) and Sponsors in conducting pharmacovigilance activities. In this article, we provide a comprehensive official Q&A addressing key aspects of China’s GVP, helping stakeholders better understand compliance, documentation, and reporting processes.
1. How to conduct PV work by MAH and Sponsor after China GVP 2021 was released?
The Marketing Authorization Holder (MAH) and the Sponsor authorized to conduct clinical trials must carefully prepare for the implementation of the regulations. They should participate in relevant training, master the core principles and content of the regulations, establish and improve a drug vigilance system, and carry out pharmacovigilance activities according to the requirements of the regulations.
2. What are the characteristics of the new regulations?
The new China GVP regulations are the first pharmacovigilance-related document issued after the revision of the Drug Administration Law of the People’s Republic of China. It reflects the concept of full lifecycle management of drugs, adheres to the principles of risk management, clarifies the responsibility of MAHs and Sponsors, and aligns with international pharmacovigilance practices.
3. How to connect the relevant requirements of new and old regulations?
The GVP is formulated based on the Drug Administration Law and the Vaccine Administration Law. If other regulatory documents conflict with the GVP, the GVP takes precedence from its formal implementation date.
4. Regarding registration in the National Adverse Drug Reaction (ADR) Monitoring System
MAH must complete registration in the ADR Monitoring System. Those already registered in the Direct Reporting System don’t need to re-register. New registrants must complete the registration within 60 days from the announcement date, and changes in user or product information must be updated within 30 days.
5. Issues Regarding Important Pharmacovigilance Documents
The GVP requires MAH to designate a Qualified Person for Pharmacovigilance (QPPV) responsible for the operation and continuous improvement of the system. Important documents include the Pharmacovigilance System Master File (PSMF), post-market safety study plans, PSURs, and pharmacovigilance plans. When used in China, documents from overseas must be translated into Chinese and reviewed by the designated QPPV.
6. Regarding PSMF Management
MAH must create and maintain a PSMF, describing the pharmacovigilance system and activities. It must be continuously updated, and regulatory authorities may require it to be provided as needed.
7. Will changes in MAH user information or product information affect ADR reporting?
Changes to user or product information in the system do not affect reporting adverse reactions. For unregistered MAHs, they must complete registration to proceed with product information updates and reporting.
8. The frequency of submitting regular safety update reports for imported drugs
Imported drugs must follow the GVP submission frequency for Periodic Safety Update Reports (PSURs) based on their registration classification. For innovative or improved new drugs, they should be submitted annually until the first license renewal, then every five years. Specific requirements should follow approval document guidelines.
9. How to define “major” in the context of major risk assessments?
The GVP requires the Drug Safety Committee to assess major risks. The MAH must determine if a situation qualifies as a major risk or emergency drug incident based on product safety characteristics and its public health impact.
10. What guiding principles will be issued to help MAH with pharmacovigilance activities?
The National Medical Products Administration (NMPA) has issued several guidelines to assist MAHs, such as the “Pharmacovigilance Inspection Guidelines” and the “Guideline for Writing the Pharmacovigilance System Master File.” Other guidelines, like the “MedDRA Coding Guideline for MAHs,” have also been released to support pharmacovigilance activities.
11. What issues should MAH pay attention to when conducting internal audits?
Internal audits are required to review the pharmacovigilance system. MAHs can conduct audits independently or hire external experts but must ensure independence. Key pharmacovigilance activities should be reviewed based on risk prevention.
12. What are the special requirements for innovative and improved drugs?
For innovative and improved drugs, the GVP requires enhanced post-market surveillance and increased signal detection frequency. PSURs must be submitted annually until the first license renewal, then every five years thereafter.
13. How should MAH report if overseas authorities require suspension or withdrawal due to adverse drug reactions?
MAH must report to the national drug regulatory authorities and ADR monitoring institutions within 24 hours if overseas authorities require suspension or withdrawal of the product due to adverse drug reactions.
14. What issues should MAH consider when entrusting pharmacovigilance activities within a group?
When delegating pharmacovigilance within a group, the MAH remains legally responsible. MAH must ensure the authenticity, accuracy, and traceability of pharmacovigilance activities through agreements or written procedures, and conduct regular audits of the entrusted parties.
How We Can Help
Navigating GVP compliance in China can be complex, but our expert team is here to assist. Whether you need support with Chinese PV audits and services, we offer tailored solutions to meet your needs.
Contact Us info@accestra.com or visit China PV Hub to learn more.