- About MedDRA
The need for a standardised medical terminology was identified by the ICH in the 1990s since there was not a standard terminology available that provided the scope and level of granularity needed by regulatory authorities and industry. In the past, the terminologies in use, such as the FDA’s COSTART, WHO-ART, J-ART, H-ARTS, ICD-9 and ICD-9CM were updated so infrequently that individual users created their own version and standardisation was lost.
MedDRA was based on a terminology belonging to the Medicines and Healthcare products Regulatory Agency (MHRA) of UK (previously named Medicines Control Agency) and was developed using the ICH process by the ICH partners, including WHO. The following significant milestones led to the initial release of MedDRA:
1990 - No standard international medical terminology
1993 - Working party of EU regulatory authorities and industry representatives reviewed and amended the UK terminology then called MEDDRA.
October 1994 - ICH adopted MEDDRA Version 1.0 as basis for international terminology. An ICH M1 Expert Working Group was formed to further develop the terminology.
February 1996 - Version 1.0 was released for alpha testing by pharmaceutical companies and regulatory authorities.
July 1997 - ICH agreed to the Version 2.0 and renamed the terminology MedDRA for Medical Dictionary for Regulatory Activities.
May 1998 - ICH Steering Committee established the ICH MedDRA Management Board.
November 1998 - MedDRA Maintenance and Support Services Organization (MSSO) was contracted to maintain and support MedDRA by IFPMA as a trustee of ICH.
January 1999 - Japanese Maintenance Organization (JMO) was established.
March 1999 - Initial version of MedDRA (Version 2.1) was available from the MedDRA MSSO and the Japanese version from the JMO.