MedDRA

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MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry throughout the entire regulatory process, from pre-marketing to post-marketing activities, and for data entry, retrieval, evaluation, and presentation. In addition, it is the adverse event classification dictionary endorsed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). MedDRA is used in the US, European Union, and Japan. Its use is currently mandated in Europe and Japan for safety reporting.

MedDRA is managed by the MSSO (Maintenance and Support Services Organization), an organization that reports to the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). MedDRA is free for regulators and priced according to company revenue for industry.

MedDRA version is released twice a year (March and September). Currently version 10.0 is slated for March 2007 release. MedDRA is updated continuously by subscriber change requests to add a new medical concept that is yet to be in MedDRA etc. The decisions are made by international medical officers on how to map the terminology within the grouping categories according to a general consensus based on language considerations internationally. The Japanese counterpart for MSSO is called JMO.

The FDA has committed to keeping current on MedDRA, and it has become the standard for adverse event reporting in the USA.

The MedDRA dictionary is organized by System Organ Class (SOC), divided into High-Level Group Terms (HLGT), High-Level Terms (HLT), Preferred Terms (PT) and finally into Lower-Level Terms (LLT). The Current MedDRA version is 9.1 (September 2006).