4 June 2012

The Management Board Welcomes the Recent Launch of the MedDRA Version Analysis Tool

Fukuoka, 3 June 2012 – The MedDRA Management Board met in Fukuoka, Japan on 2 - 3 June 2012.

The MSSO provided data on user uptake of the new MedDRA Version Analysis Tool (MVAT). MVAT assists users in understanding the differences between any two versions of MedDRA. Over 150 organisations have used MVAT since its launch in February 2012.

For the fifth time, the MedDRA Management Board welcomed the Regional Harmonisation Initiative and Drug Regulatory Authority/Department of Health members of the ICH Global Cooperation Group to a special session. During this special session, the Board heard from representatives of various regulatory authorities who described their experiences of implementing MedDRA in their pharmacovigilance systems, including interoperability considerations (i.e., links between MedDRA and other standard terminologies) and use of MedDRA for medication error reporting.

The Japanese Management Board (JMB) reported on the activities of the Japanese Maintenance Organisation (JMO). The JMB reported that the number of JMO subscribers has grown mainly due to increased numbers of web-type subscribers from academia.

The Board authorised the MSSO to make changes to neoplasm terms in MedDRA (new terms and revised placement of existing terms) based on a 2011 Blue Ribbon Panel. The aim is increased histologic specificity in MedDRA to improve coding and analysis of oncology data. These changes will begin in MedDRA Version 16.0 (March 2013).

The MSSO informed the Board that an upgraded version of the MedDRA Desktop Browser will be available this summer to MedDRA users. The browser will have several enhancements such as synonym lists and display of the history of terms in all MedDRA languages, and an ability to have a network distribution.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) described a recently launched project to map a subset of SNOMED-CT© terms to MedDRA. This will facilitate the MHRA’s integration of adverse reaction data from electronic health records in the UK, currently coded with SNOMED-CT©, into their MedDRA-coded data collected from their eYellow Card system.

The next meeting of the Board will be on 10–11 November 2012 in San Diego, USA.

For further information, please contact:
ICH Secretariat, Chemin Louis-Dunant, 15, P.O Box 195, 1211 Geneva 20, Switzerland. Tel: +41 22 338 3206, fax: +41 22 338 3230, e-mail: admin@ich.org, website: www.ich.org

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