ICH E2D Post-approval safety data management - Scientific guideline
HumanScientific guidelines
The ICH E2D guideline has been 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 guideline provides guidance on definitions and standards for post-approval safety information management and reporting, as well as on good case management practices.
Since its original publication new sources of post-approval safety information have emerged or are more frequently applied (e.g. digital platforms, market research programs, patient support programs) which vary in characteristics and contributions to the quality of the safety data received.
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.
Keywords: Adverse event (AE), adverse drug reaction (ADR), spontaneous reports, solicited reports, organised data collection system (ODCS), digital platform, patient support program (PSP), market research program (MRP), lack of efficacy, overdose, abuse, misuse, medication error, occupational exposure, pregnancy and lactation exposure, post-approval drug safety information, individual case safety report (ICSR), duplicate management , follow-up information, reporting timeframes.