EMA: Regulatory and procedural guideline: Implementation plan for the \'Note for guidance - EudraVigilance Human – Processing of safety messages and individual case safety reports (ICSRs) (EMEA/H/20665/04/Final Rev. 2)

The scope of the revised note for guidance is to improve the quality and consistency of ICSRs reported electronically. This has been achieved by strengthening of the validation processes of ICH E2B(R2) data elements and by making mandatory the population of certain ICH E2B(R2) data elements in the ICSRs.