One of the important visions of ICH is the exchange of electronic documents and records. In line with this, ICH has created important electronic standards such as the electronic Common Technical Document (ICH M8 eCTD) and the electronic Individual Case Safety Report (ICH E2B ICSR). MedDRA supports the use of these standards which increase the efficiency with which important regulatory information is shared.
The CTD is used by pharmaceutical companies to assemble all quality, safety and efficacy information into one format for the submission of new drug applications to ICH regulatory authorities. The CTD is organised into five modules. Module 1 is region specific and Modules 2 (Quality Overall Summary), 3 (Quality), 4 (Safety) and 5 (Efficacy) are intended to be common for all regions. MedDRA is an important component of the CTD, being used within Module 5 to summarise adverse event data in a standardised way.
The ICH E2B standard was developed to support the reporting of ICSRs for both pre- and post-approval periods in the ICH regions. MedDRA is a necessary part of the electronic submission of ICSRs and is required for use in the ICH E2B standard by the following elements (as stated in the ICH E2B(R3) Implementation Guide for ICSRs Version 5.01):
|D.7.1.r.1b||Structured Medical History Information (disease / surgical procedure / etc.)|
|D.8.r.6b||Indication (relevant past history)|
|D.8.r.7b||Reaction (relevant past history)|
|D.9.2.r.1b||Reported Cause(s) of Death|
|D.9.4.r.1b||Autopsy-determined Cause(s) of Death|
|D.10.7.1.r.1b||Medical History (disease / surgical procedure / etc.)|
|D.10.8.r.6b||Indication (relevant past drug history of parent)|
|D.10.8.r.7b||Reactions (relevant past drug history of parent, if any and known)|
|E.i.2.1b||Reactions / Event|
|H.3.r.1b||Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event|