China National Medical Products Administration (NMPA) officially issued the Good Pharmacovigilance Practices (GVP) on May 13, 2021, after releasing the consultation draft in December last year. GVP, made for regulating and guiding pharmacovigilance activities, is set to come into enforcement on Dec. 1, 2021.
Who does GVP address?
The Chinese GVP applies to Marketing Authorization Holders (MAHs)'s pharmacovigilance activities about medicinal products and drug registration applicants with authorization to carry out clinical trials.
Pharmacovigilance activities are defined as activities to monitor, identify, evaluate and control adverse drug reactions (ADRs) or other negative reactions related to medication.
As NMPA announced GVP, the authority asked MAHs and drug registration applicants to gear up for fulfilling the GVP requirements, saying they should establish pharmacovigilance systems to organize relevant activities in line with laws and regulations.
NMPA also noted that MAHs should register at China National ADR Monitoring System within 60 days from GVP's release date.
Covering Every Stage of Drug Life Cycle
The GVP has comprehensive contents, whose effects cover every phase of the drug life cycle.
Content of Chinese Good Pharmacovigilance Practices
1. General Principles
2. Quality Management
Entrusted Management by Third-party
3. Personnel and Resources in the Organization
Organization (of Drug Safety Committee and Pharmacovigilance Departments)
Personnel and Training
Equipment and Resources
4. Monitoring and Report
Evaluation and Feedback of the Report
5. Risk Identification and Assessment
Risk Signal Detection
Post-market Study on Drug Safety
Periodic Safety Update Report (PSUR)
6. Risk Control
Measures for Risk Control
7. Documentation, Records and Data Management
Documents on Pharmacovigilance System, Standards and Procedure
Master Files on Pharmacovigilance System
Records and Data
8. Pharmacovigilance During Clinical Trial
Risk Monitoring, Identification, Assessment and Control
9. Supplemental Principles
Highlights of GVP
1. Responsible Subject
MAHs are the responsible subjects for pharmacovigilance and should assume the legal obligation even if pharmacovigilance affairs are entrusted to a third party.
An entrusted party should be a legal person in China that is capable of ensuring the effective operation of pharmacovigilance affairs.
2. Adverse Drug Reaction Report