How should MedDRA be cited in publications?
The following are guidelines for the use of MedDRA in publications: MedDRA text terms may be used in examples, but the examples need to be limited in size (less than 100 terms). MedDRA numeric codes are not permitted to be used. It should be cited in the article that MedDRA® the Medical Dictionary for Regulatory Activities terminology is the international medical terminology developed under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The following acknowledgement statement needs to appear in all articles referencing MedDRA: MedDRA® is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Copies of all articles referencing MedDRA should be emailed to MSSOHelp@ngc.com.
