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.
1. Who does GVP address?
The Chinese GVP applies to pharmacovigilance activities of
Marketing Authorization Holders (MAHs); 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) and/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.
2. Covering Every Stage of Drug Life Cycle
The GVP has comprehensive contents, whose effects cover every phase of the drug life cycle.
Contents 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
Evaluating and Handling the Report
5. Risk Identification and Assessment
Risk Signal Detection
Drug Safety Post-market Study
Periodic Safety Update Report (PSUR)
6. Risk Control
Risk Control Measures
7. Documents, Records and Data Management
Documents on Pharmacovigilance System, Standards and Procedure
Pharmacovigilance System Master File (PSMF)
Records and Data
8. Pharmacovigilance During Clinical Trial
Risk Monitoring, Identification, Assessment and Control
9. Supplemental Provisions
3. Highlights of GVP
1. Responsible Subject
MAHs / drug registration applicants 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 entity in China and capable of ensuring the effective operation of pharmacovigilance affairs.
2. Adverse Drug Reaction Report
MAHs should collect information on suspected ADRs from various sources, including hospitals, manufacturers and distributors.
The information should cover the situations inside and outside China if the drug product is on Chinese and overseas markets.
3. Periodic Safety Update Report (PSUR)
MAHs of innovative or improved new drugs should submit a PSUR to NMPA every year since marketing approval. The submission frequency will change to one update every five years after the re-registration of the drug product.
For drugs under other classifications, MAHs should submit the report every five years since marketing approval.
PSUR is not required for active pharmaceutical ingredients (APIs), in vitro diagnostic products (IVDs), traditional Chinese medicine (TCM) ingredients and decoction pieces of TCM.
4. Pharmacovigilance System Master File (PSMF)
MAHs should create and update master files, which include at least the following items:
Organization related to pharmacovigilance activities;
Information of the responsible person of pharmacovigilance;
Specialized personnel for pharmacovigilance;
Suspected adverse reactions and their information sources;
Information tool or system for pharmacovigilance activities;
Pharmacovigilance management system and its operation standards & procedure;
Operation status of the pharmacovigilance system;
Entrustment of pharmacovigilance activities;
documents on pharmacovigilance system, operation standards & procedure,
internal review report,
record of master file revisions, etc.
4. Influence on the Pharmaceutical Industry
GVP is much more comprehensive than the previous pharmacovigilance regulations, which mainly focused on ADRs. It provides official guidance for Chinese pharmaceutical companies on almost every step in pharmacovigilance activities.
For some overseas companies, the release of the new GVP means that the old time when they paid not as much attention to pharmacovigilance in China as other markets should end. Instead, they need to comply with the new GVP requirements, especially those particular to China.
For any detail in GVP, please contact ChemLinked BaiPharm via firstname.lastname@example.org.