| Medical Dictionary For Regulatory Activities |
Article Index for Medical |
Information AboutMedical Dictionary For Regulatory Activities |
| CATEGORIES ABOUT MEDDRA | |
| pharmacology | |
| classification systems | |
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MedDRA is managed by the MSSO (Maintenance and Support Services Organization), an organization that reports to the International Federation Of Pharmaceutical Manufacturers And Associations (IFPMA). MedDRA is free for regulators and priced according to company revenue for industry. MedDRA is also available in Japanese. The Japanese counterpart for MSSO is called JMO. The MSSO updates MedDRA from subscriber change requests to add a new medical concept that is yet to be in MedDRA or to change an existing concept. 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 MSSO releases updated MedDRA versions twice a year - in March and September. The March release is the main annual release and contains LLT and PT changes, and changes at the HLT level and above. The September release typically contains changes only at the LLT and PT level. The September 2007 Version 10.1 release is the current version. 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). In addition, the MedDRA dictionary includes Standardized MeddDRA Queries (SMQs). SMQs are groupings of terms that relate to a defined medical condition or area of interest. SEE ALSO
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