Generated Narrative: NamingSystem mdr Summary Defining URL http://terminology.hl7.org/NamingSystem/mdr Version 3.0.0 Name MedDRA Title Medical Dictionary for Regulatory Activities Status active Definition MedDRA is a multilingual standardised international medical terminology which can be used for regulatory communication and evaluation of data pertaining to medicinal products for human use. MedDRA is designed for use in the registration, documentation and safety monitoring of medicinal products through all phases of the development cycle (i.e., from clinical trials to post-marketing surveillance).#13; MedDRA is structured as a five level hierarchy. System Organ Classes (SOCs) are the broadest terms (e.g., Cardiac disorders, Investigations). The lowest level of the terminology is the Lowest Level Term (LLT) level. Publisher MedDRA Maintenance and Support Services Organization (MedDRA MSSO); Mr. Patrick Revelle; MSSO Director Identifiers Type Value Preferred OID 2.16.840.1.113883.6.163 true URI https://www.meddra.org true URI http://terminology.hl7.org/CodeSystem/mdr false
Medical Dictionary for Regulatory Activities
MedDRA Maintenance and Support Services Organization (MedDRA MSSO); Mr. Patrick Revelle; MSSO Director
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
MedDRA Maintenance and Support Services Organization (MedDRA MSSO)
MedDRA is a multilingual standardised international medical terminology which can be used for regulatory communication and evaluation of data pertaining to medicinal products for human use. MedDRA is designed for use in the registration, documentation and safety monitoring of medicinal products through all phases of the development cycle (i.e., from clinical trials to post-marketing surveillance).#13; MedDRA is structured as a five level hierarchy. System Organ Classes (SOCs) are the broadest terms (e.g., Cardiac disorders, Investigations). The lowest level of the terminology is the Lowest Level Term (LLT) level.