不良反应处理流程图-英文版

Feedback Management of Electronic and Paper Materials for Individual Drug ADR/Event Cases

Medical Institutions & Retail Pharmacies (Sales Dept.)

 Telephone & Complaints (Pharmacovigilance Dept.)

Pre-Marketing Clinical Research (Research Institute)

Clinical Research

Reportable Cases

 Academic Literature (Pharmacovigilance Dept. & Research Institute)

Non-Reportable Cases

 Overseas Adverse Events

New drugs (during monitoring period): Once per year

Report Archiving

PSUR Summary & Analysis

Other products: Once every 5 years

Forwarded to Pharmacovigilance Department

Market Research (Marketing Dept.)

Legal Litigation Channels

Drug Distributors (Sales Dept.)

Patient Support Projects (Marketing Dept.)

• Urgent/severe cases: File within 15 days• Critical urgent cases: Report to the Municipal Drug and Medical Device Safety Committee immediately; complete filing and report to the drug regulatory authority within 7 days• General cases: File in the drug adverse reaction monitoring system within 30 days

Feedback on Individual Drug ADR/Event Reports

Solicited Report Collection Channels

Post-Marketing Clinical Research (Research Institute)

Report Collection

Time Limits

Drug Key Monitoring (Research Institute)

 Internet & Related Channels

Report Feedback

Patient Education Activities (Marketing Dept.)

Observational Epidemiological Research (Research Institute)

Report Handling

Non-Solicited Report Collection Channels

Market Projects

Regulatory Department Sources

Time Limit