18 November 2016

Osaka, Japan 2016 – The MedDRA Management Board met in Osaka, Japan on 5-6 November 2016.

MedDRA Subscriptions

The Board is pleased to announce that there will be a reduction in MedDRA subscription rates for MSSO subscribers in 2017. Details will be available on the MedDRA website. This reduction is a reflection of the continued success of MedDRA as a global standard; with over 4,800 subscribing organisations worldwide, the costs of maintaining and developing the terminology can be distributed over a wider base, whilst still providing the same high standard of tools and services to MedDRA users.

Standardised MedDRA Queries

Five Standardised MedDRA Queries (SMQs) will go into production in March 2017 for MedDRA Version 20.0. 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 noted the publication of 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 was made available in August 2016 on the CIOMS website.

ICH M1 Points to Consider

The Board noted the work of the ICH M1 Points to Consider (PtC) Working Group in facilitating MedDRA’s global uptake. The Working Group has developed 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. These condensed documents will be made available to MedDRA users in 2017. The Board also approved the Working Group’s proposal to develop a companion document to the PtC documents, available in English and Japanese, which would provide more detailed guidance, examples, and “Questions and Answers” on topics of regulatory importance such as data quality, medication errors, and product quality issues.

Unqualified Test Name Term List

The Board noted that the MSSO has published a list of unqualified test name terms as a toto improve data quality. The list and an explanatory document are available under RelatedLinks on the Support Documentation page on the MedDRA website.

MSSO ISO Recertification

The Board noted that the MSSO achieved ISO 9001 recertification in August 2016 followsuccessful completion of an audit.

Other important initiatives and developments

The Board was also updated on other important initiatives and developments. This includethe development of a web-based self service application which will allow users to access MedDRA subscription information online; and MSSO participation in the Innovative Medicines Initiative’s WEB-RADR (Recognising Adverse Drug Reactions) project lookinat the integration of MedDRA in mobile technologies and social media data monitoring asnew tools in pharmacovigilance; The next scheduled meeting of the Board will be on 27-28 May 2017 in Canada.

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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