14 December 2015

ICH MedDRA Management Board Notes New SOC and New SMQs for MedDRA Version 19.0

Jacksonville, 6 December 2015 – The MedDRA Management Board met in Jacksonville, FL, USA on 5-6 December 2015.

SOC Product issues
The MSSO confirmed to the Board the implementation of the new System Organ Class (SOC) Product issues in March 2016 for MedDRA Version 19.0. This SOC will include terms relevant for issues with product quality, devices, manufacturing quality systems, product supply and distribution, and counterfeit products. One of the goals of incorporating product quality terms into MedDRA is to support the recording of product quality issues and any associated adverse events by using a single terminology. An initial set of terms in this new SOC is contained in the supplemental files which can be accessed now on the MedDRA website.

Standardised MedDRA Queries
Four Standardised MedDRA Queries (SMQs) will go into production in March 2016 for MedDRA Version 19.0. Three SMQs are new topics: Drug reaction with eosinophilia and systemic symptoms syndrome, Hypoglycaemia, and Medication errors. The fourth, Pulmonary hypertension, is a revision of the existing SMQ based on a new classification of the condition.

The Board acknowledged the significant efforts of the Council for the International Organization of Medical Sciences (CIOMS) SMQ Implementation Working Group (IWG) and renewed the Memorandum of Understanding between ICH and CIOMS for a further year of development of new SMQs.

In addition, the Board endorsed the second edition of the CIOMS SMQ IWG report, « Development and Rational Use of Standardised MedDRA Queries (SMQs): Retrieving Adverse Drug Reactions with MedDRA”. This report is scheduled to be published in 2016 and can be obtained on the CIOMS website.

MedDRA Subscriptions
The Board is pleased to announce that there will be no increase in MedDRA subscription rates for 2016. This is the result of continued growth of MedDRA subscribers throughout the world – currently numbering over 4,500 organisations - and increased efficiencies to contain costs of maintenance and development of the terminology. The Japanese Management Board reported on the Japanese Maintenance Organization’s (JMO) activities and noted an increase in the number of subscribers.

WEB-RADR (Recognising Adverse Drug Reactions)
The MSSO reported that it has joined the Innovative Medicines Initiative’s WEB-RADR project as one of 20 contributing partners evaluating mobile technologies and social media as new tools in pharmacovigilance.

Software Tools
The MSSO released an updated MedDRA Desktop Browser (MDB) in October 2015. This latest version of the MDB updates the user interface and the functions to match the Web-Based Browser (WBB). Additionally, the MDB includes an option to change the user interface to any of the currently supported MedDRA languages, as well as supporting multiple languages and the display of hierarchy information in search result outputs.

The next scheduled meeting of the Board will be on 11-12 June 2016 in Europe.

For further information, please contact:

ICH Secretariat 
Chemin des Mines 9 
P.O Box 195, 1211 Geneva 20, Switzerland 
Tel: +41 22 338 3206 
Fax: +41 22 338 3230 
E-mail: admin@ich.org - Websites: www.ich.org / www.meddra.org

Download the PDF version of the Press Release