PharmD Info

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.
  Download Here

• 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.
  Download Here

• 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.
  Download Here

• E2E: It provides guidelines on Pharmacovigilance planning.
  Download Here

• 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.
  Download Here