MSSO(Maintenance and Support Services Organization)

MedDRA is managed by the MSSO (Maintenance and Support Services Organization-as the repository, maintainer, and distributor of MedDRA as well as the source for the most up-to-date information regarding MedDRA and its application within the bio-pharmaceutical industry and regulators. MedDRA subscribers submit proposed changes to the terminology. The MSSO includes a group of internationally based physicians who review all proposed subscriber changes and provide a timely response directly to the requesting subscriber.), 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 process of change requests is performed within 7 calendar days from initial receipt by the MSSO. Approved Change Requests are designated as supplemental changes to MedDRA and are posted on the MSSO Web site for review by all subscribers. It should be noted that supplemental releases are not considered “official” MedDRA releases. Supplemental terms, however, will be included in the “official”, scheduled version release.
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 2010 Version 13.1 release is the current version.
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 MedDRA Queries (SMQs). SMQs are groupings of terms that relate to a defined medical condition or area of interest. “The MedDRA dictionary itself poses significant challenges. It is new, complex, and roughly 10 times larger than COSTART or WHO-ART.” MedDRA also brings its own challenges concerning the performing of autoencoding failure resolution, dictionary updates, and version control.