Last Updated on July 27, 2026
Following guidelines are intended to help the industry and other applicants to meet the regulatory requirements related to the Pharmacovigilance.
1. General Guidelines for Pharmacovigilance
- Guidelines on National Pharmacovigilance System
- Good Pharmacovigilance Practices for Registration Holder
- Industry E-Reporting Manual for Registration / Marketing Authorization Holders
- Guidelines On Pharmacovigilance for Public Health Programmes
2. Guidelines to Report Adverse Events
- Adverse Events Reporting Guidelines for Patients, Caretakers and Consumers
- Adverse Event Reporting Guidelines for Healthcare Professionals
3. Medication Safety