15 June 2015

ICH MedDRA Management Board Notes New MedDRA Tools Supporting Multiple Languages

Fukuoka, 7 June 2015 – The MedDRA Management Board met in Fukuoka, Japan on 6-7 June 2015.

Software Tools
The MSSO reported on the launch of the new Web-Based Browser (WBB). Feedback has been positive with a growing pool of users. The WBB supports all MedDRA languages, and allows users to view multiple languages simultaneously. The WBB features options for search result displays, and Research Bin import and export functions. A User Interface in all languages is planned in a future upgrade. The MSSO also reported on the release of an updated MedDRA Version Analysis Tool (MVAT) application in May 2015. This is the first MedDRA tool that allows users to select their preferred language for the User Interface from the 11 MedDRA languages. Other MVAT enhancements include data reports in all languages, improved term history display, the option to filter reports by primary System Organ Class (SOC), and improved reports for SMQ changes.

27th System Organ Class
The Board confirmed the implementation of a 27th SOC in March 2016 for MedDRA Version 19.0 which will be called Product issues. This new SOC will include terms relevant for issues with product quality, devices, manufacturing quality systems, product supply and distribution, and counterfeit products. A set of complex change proposals for the SOC Product issues will be posted for comments on the MedDRA website from July 2015 until September 2015.

ICH M1 Points to Consider
The ICH M1 Points to Consider Working Group is planning to update the Points to Consider documents for MedDRA Version 19.0 to provide guidance to users and to reflect changes in MedDRA relating to the implementation of the new SOC Product issues.

MSSO & JMO Continued Evolution
The Japanese Management Board reported on the Japanese Maintenance Organization’s (JMO) activities, and noted an increase in subscribers compared to the same period last year. The MSSO also reported on the growth of its subscriber base. Future areas of focus for the MSSO include supporting the global use of MedDRA, exploring interoperability between MedDRA and other medical terminologies, and investigating the use of new technologies for pharmacovigilance purposes.

The next scheduled meeting of the Board will be on 5-6 December 2015 in Jacksonville, FL, USA.

For further information, please contact the ICH Secretariat at admin@ich.org

Download the PDF version of the Press Release