Guidance on MedDRA version upgrade

27 April 2007, Updated 26 September 2016

MedDRA (Medical Dictionary for Regulatory Activities) is a code book of medical terminology developed by the ICH (International Conference on Harmonisation). The MSSO (Maintenance and Support Services Organization) is responsible for the maintenance.

MedDRA is used for the coding of suspected adverse drug reactions, indications and the like in order to submit electronic reports on adverse drug reactions to the European safety database (EudraVigilance) and between the pharmaceutical industry and the competent authorities.

A new MedDRA update is released every half year. The exact implementation date of a new version should be coordinated between the parties of the network to ensure the communication between them.