MedDRA
Encyclopedia
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 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 March 2011 Version 14.0 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 MedDRA Queries (SMQs). SMQs are groupings of terms that relate to a defined medical condition or area of interest.
Medical terminology
Medical terminology is a vocabulary for accurately describing the human body and associated components, conditions, processes and process in a science-based manner. Some examples are: R.I.C.E., trapezius, and latissimus dorsi. It is to be used in the medical and nursing fields...
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
Adverse event
An adverse event is any adverse change in health or side effect that occurs in a person who participates in a clinical trial while the patient is receiving the treatment or within a previously specified period of time after the treatment has been completed.AEs in patients participating in...
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
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
, and Japan
Japan
Japan is an island nation in East Asia. Located in the Pacific Ocean, it lies to the east of the Sea of Japan, China, North Korea, South Korea and Russia, stretching from the Sea of Okhotsk in the north to the East China Sea and Taiwan in the south...
. 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 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 March 2011 Version 14.0 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 MedDRA Queries (SMQs). SMQs are groupings of terms that relate to a defined medical condition or area of interest.
See also
- COSTARTCOSTARTThe Coding Symbols for a Thesaurus of Adverse Reaction Terms was developed by the United States Food and Drug Administration for the coding, filing and retrieving of post-marketing adverse reaction reports. COSTART provides a method to deal with the variation in vocabulary used by those who...
- Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT)
- WHOARTWHOARTThe WHO Adverse Reactions Terminology is a dictionary meant to serve as a basis for rational coding of adverse reaction terms. The system is maintained by the Uppsala Monitoring Centre , the World Health Organization Collaborating Centre for International Drug Monitoring.-Structure:* 32...