Who determines what terms are added to MedDRA?
The addition of terms to MedDRA is driven by the subscriber change request process. A term that has been submitted by a subscriber is added to MedDRA when it meets all of the following criteria: must be unambiguous, within scope of the terminology, and must be medically valid and internationally acceptable by an international panel of MSSO medical personnel, and must have a justification that explains the need for the term before being incorporated into MedDRA.
Related Questions
- My company is small, so do my requests to add terms to MedDRA receive the same consideration as a large pharmaceutical company?
- Why has a new Ethnic categories hierarchy been added to the January 2004 release of Clinical Terms (the Read codes)?
- Are all supplemental terms reflected in the new releases of MedDRA?
