20 July 2016

The ICH MedDRA Management Board met in Lisbon, Portugal on June 11-12, 2016 where ICH concluded its internal process for the award of a new 7-year contract for the MedDRA Maintenance and Support Services Organization (MSSO).

MedDRA, the Medical Dictionary for Regulatory Activities, is a rich and highly specific standardised medical terminology developed by ICH to facilitate sharing of regulatory information internationally for medical products used by humans. It is used for registration, documentation and safety monitoring of medical products both before and after a product has been authorised for sale. The ICH MedDRA Management Board provides technical and financial oversight. The MSSO is contracted by ICH and tasked with maintaining, developing and distributing MedDRA.

A new call for tender was launched by ICH in August 2014, with bids invited by October 31, 2014. After a thorough period of assessment, which considered aspects including medical expertise and IT expertise, strength of management and staffing that are necessary to ensure the high quality of MedDRA as well as financial aspects, the ICH’s Tender Evaluation Panel concluded the negotiation of a new contract with the selected bidder. ICH is pleased to announce that a new 7-year contract has been awarded as a result of which Northrop Grumman’s Health Solutions Business Unit will serve as the MSSO whose team is well qualified and experienced since it is already in charge of current MSSO operations.

The awarding of the new contract assures the continued viability and growth of the unique asset that is MedDRA.

In Lisbon, the Board acknowledged MedDRA’s success with the further growth in the number of MedDRA subscribers worldwide to over 4,500 organisations. The Board also discussed further facilitating MedDRA’s global uptake. Current work by the ICH M1 Points to Consider (PtC) Working Group was recognised as important in this regard. The Working Group, which also met in Lisbon (June 13-16), discussed the development of condensed versions of the PtC documents for translation into all MedDRA languages (except English and Japanese versions which will remain in full) to support the implementation and use of MedDRA worldwide.

The Board was also updated on other important initiatives and developments. This included a smooth implementation of the 27th SOC Product issues in MedDRA Version 19.0 in March 2016; release in May 2016 of an updated MedDRA Web-Based Browser (WBB) with more multilingual features; MSSO participation in the Innovative Medicines Initiative’s WEB-RADR (Recognising Adverse Drug Reactions) project looking at the integration of MedDRA in mobile technologies and social media data monitoring as new tools in pharmacovigilance; and the successful achievement of ISO 9001 certification by the JMO (Japanese Maintenance Organisation) in December 2015.

The next scheduled meeting of the Board will be on November 5-6, 2016 in Osaka, Japan.

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

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