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
