- 24 Sep 2022, 18:10 #5294
ICH guidelines related to Pharmacovigilance are listed below; ICH E2A to E2F guidelines deals with pharmacovigilance.
- E2a: E2a give guidelines for Clinical Safety Data Management. It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug development.
- E2b: E2B guidelines for Data elements transmission of ICSRs (Individual Case Safety Reports). It provides guidelines on clinical safety data management and ICSR data elements transmission.
- E2c: It provides guidelines on PSURs (Periodic Safety Update Reports) of marketed drugs, which are having role in Periodic benefit risk evaluation report.Download Here
- E2D: It provides guidelines for Post approval safety data management.
- E2E: It provides guidelines on Pharmacovigilance planning.
- E2F: Development Safety Update Report: It provides guidance on DSUR. It is the data from the Investigational drugs in the clinical trials, with or without having a market approval. Sponsors required to submit DSUR on every year.