BILLEV PHARMA EAST

NEWS

6 June 2024

ICH E2D(R1) Guideline on Post-Approval Safety Data: Public Consultation Open until June 22nd 2024

The ICH E2D guideline has been first published in May 2003 to establish an internationally standardized procedure to improve the quality of post-approval drug safety information and to harmonise the way of gathering and reporting it.

The revised version of the guideline (ICH E2D(R1)) released for public consultation provides updates on the definitions, standards, and regulatory guidance for the management and reporting of post-approval drug safety information with the aim to support appropriate safety surveillance of medicinal products based on the current practices and needs. An explanatory note supports the E2D(R1) Step 2 public consultation by detailing proposed updates to the ICH E2B(R3) reporting format for ICSRs, aiming to better categorize cases from various data sources.

Public consultation on ICH E2D(R1) Guideline on post-approval safety data Step 2b – Revision 1 is open until June 22nd 2024.

More information can be found on EMA’s website: ICH E2D Post-approval safety data management – Scientific guideline | European Medicines Agency (europa.eu)