ICH E2D Post-approval safety data management

  • Email
  • Help
Current effective version

Adopted guideline

Reference numberCPMP/ICH/3945/03
Published30/11/2003
Effective from01/05/2004
KeywordsExpedited reporting, post-approval drug safety, individual case safety reports, adverse event (AE), adverse drug reaction (ADR), spontaneous reports, solicited sources, lack of efficacy, overdose, pregnancy exposure, follow-up information, reporting time frames
DescriptionThis document aims to establish an internationally standardized procedure to improve the quality of post-approval safety information and to harmonise the way of gathering and reporting information. It provides guidance on definitions and standards for post-approval expedited reporting, as well as good case management practices.

How helpful is this page?

Average rating:

 Based on 1 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
0 ratings
0 ratings
1 ratings
    

Tell us more