14 June 2019

Amsterdam, the Netherlands, 2019 – The MedDRA Management Committee met in Amsterdam, the Netherlands on 1-2 June 2019.

MedDRA Celebrates its 20th Anniversary
The MedDRA Management Committee noted that 1 March 2019 marked the 20th anniversary of the first release of MedDRA. From its beginning, starting with 254 subscribers in 1999, MedDRA has experienced remarkable growth with currently over 5,700 subscribing organisations in over 125 countries using 12 language translations. The terminology has dynamically evolved over the 20-year span to support the needs of users from medical and regulatory perspectives. The MedDRA Management Committee recognised the contributions of users in driving the growth of the terminology and thanked the MSSO and JMO for their efforts in maintaining and developing MedDRA as a true international standard.

Supporting the Use of MedDRA Worldwide
The MedDRA Management Committee noted major achievements in supporting the global implementation and use of MedDRA, in accordance with the five-year strategic plan. ICH has strengthened its regionally-based approach in facilitating implementation of MedDRA with local MSSO personnel providing training and Help Desk support. The MedDRA Management Committee noted that the Russian translation of MedDRA was released on 15 March 2019 in MedDRA Version 22.0 and that the Korean and Brazilian Portuguese translations of MedDRA are progressing on schedule. The global MedDRA training programme is expanding with a particular focus on China, India, Latin America, the Republic of Korea, and Russian-speaking countries. The MedDRA Management Committee also welcomed the continuing collaboration with WHO in supporting countries transitioning from WHO-ART to MedDRA for pharmacovigilance activities.

ISO certification
The MedDRA Management Committee noted that the MSSO and the JMO had both achieved recertification with the ISO 9001:2015 standard following successful completion of audits.

The MedDRA Management Committee noted the progress of the IMI WEB-RADR 2 project in which ICH and SNOMED International are participating. The work to produce a bi-directional mapping between the two terminologies is on track with a future maintenance and access model being explored.

ICH M1 Points to Consider
The MedDRA Management Committee acknowledged the work of the ICH M1 Points to Consider (PtC) Working Group and noted that the medication errors section of the PtC Companion Document is being updated based on user feedback and will be released by December 2019.

Software Tools
The MedDRA Management Committee noted the launch of the Mobile Web-Based Browser (MMB) on 30 April 2019. This browser offers similar features to the full Web-Based Browser but is tailored to the mobile computing environment. It allows users to access MedDRA on a variety of platforms on smartphones and tablets. A major upgrade to the MedDRA Desktop Browser (MDB) was also launched on 23 May 2019 to synchronise with functions available in the Web-Based Browser (WBB). This upgrade allows MedDRA users to upload data for analysis with SMQs, view primary and secondary link information, and perform advanced search functions.

The next face-to-face meeting of the MedDRA Management Committee will be on 17-18 November 2019 in Singapore.


For further information, please contact:

ICH Secretariat 
Route de Pré-Bois, 20
P.O. Box 1894
1215 Geneva, Switzerland
Tel: +41 (22) 710 74 80 

E-mail: PressRelease@ich.org - Websites: www.ich.org / www.meddra.org

Download the PDF version of the Press Release