Pharmacovigilance: how to comply with China’s Good Pharmacovigilance Practices (GVP)?
Pharmacovigilance is an important obligation for life sciences companies. Pharmacovigilance (PV), also known as drug safety, should be monitored throughout the use of medicines because adverse reactions may emerge in patients.
China’s Good Pharmacovigilance Practices (GVP)
Pharmacovigilance activities are defined as activities to monitor, identify, evaluate and control adverse drug reactions (ADRs) and/or other negative reactions related to medication.
China National Medical Products Administration (NMPA) released the Good Pharmacovigilance Practices (GVP), which has been effective since Dec. 1, 2021.
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 administrations’ inspections according to the Pharmacovigilance Inspection Guidelines.
|China’s Good Pharmacovigilance Practices (GVP)|
|Chapter 1: General Principles|
|Chapter 2: Quality Management||§ 2.1 Fundamental Requirements|
|§ 2.2 Internal Audit|
|§ 2.3 Management Entrusted to a Third-party|
|Chapter 3: Personnel and Resources of the Organization||§ 3.1 Organization|
|§ 3.2 Personnel and Training|
|§ 3.3 Equipment and Resources|
|Chapter 4: Monitoring and Report||§ 4.1 Information Collection|
|§ 4.2 Evaluating and Handling of the Report|
|§ 4.3 Report Submission|
|Chapter 5: Risk Identification and Assessment||§ 5.1 Risk Signal Detection|
|§ 5.2 Risk Assessment|
|§ 5.3 Post-market Drug Safety Study|
|§ 5.4 Periodic Safety Update Report (PSUR)|
|Chapter 6: Risk Control||§ 6.1 Risk Control Measures|
|§ 6.2 Risk Communication|
|§ 6.3 Pharmacovigilance Plan|
|Chapter 7: Management of Documents, Records, and Data||§ 7.1 Documents on Pharmacovigilance System, Standards, and Procedures|
|§ 7.2 Pharmacovigilance System Master File (PSMF)|
|§ 7.3 Records and Data|
|Chapter 8: Pharmacovigilance During Clinical Trial||§ 8.1 Fundamental Requirements|
|§ 8.2 Risk Monitoring, Identification, Assessment, and Control|
|Chapter 9: Supplemental Provisions|
To carry out the complete pharmacovigilance activities, pharma companies may find the following difficulties:
- The adverse reports come in with no fixed number;
- Heavy economic burden and workload;
- Limited internal resources to fulfil each pharmacovigilance task, etc.
Therefore, it is recommended that companies outsource pharmacovigilance activities to a professional PV provider.
BaiPharm provides comprehensive pharmacovigilance services to help clients ensure compliance with China’s GVP. Our services include but are not limited to:
China Risk Management Plans (RMPs)
- Describing safety profile with identified and potential risks;
- Planning studies for more knowledge about safety and efficacy;
- Planning risk minimizing measures and evaluate their effectiveness.
Individual Case Safety Report (ICSR) Management
- Collecting the information of suspected ADRs from multiple sources, including reports from manufacturers / distributors / medical institutions / patients / other individuals, post-market studies, data-collecting projects, academic literature, and relevant websites;
- Collecting ADRs from China and overseas markets;
- Submitting ICSRs to China’s National Drug ADR System.
Periodic Safety Update Report (PSUR) Submission
- Collecting, entering, and evaluating safety data;
- Reviewing and revising PSUR;
- Preparing periodic benefit-risk evaluation reports (PBRER) in place of PSUR.
- Searching and reviewing overseas and Chinese literature;
- Applying literature into report;
- Translating English ICSR literature into Chinese.
Why Choose BaiPharm
Our experts have achieved a thorough understanding of pharmaceutical regulations and extensive experience to provide solutions across all critical stages in the drug life cycle. We’re committed to providing clients with professional and customizable pharmaceutical regulatory compliance services, including market entry consultation and registration of prescription drugs, OTCs, APIs, excipients and packaging materials. Our constant driver is to ensure high-level professional and efficient solutions for pharmaceutical enterprises across the globe.
- CTA, BE and MRCTs in China
- Cross-Border E-Commerce Solutions
- China’s Good Pharmacovigilance Practices (GVP)
- Market Access Strategy
- Local Agency Support
- Customized Training
- Medical Translation Service