12 June 2017

Montreal, Canada 2017 – The MedDRA Management Board met in Montreal, Canada on 27-28 May 2017.

Expansion of MedDRA Use

The MedDRA Maintenance and Support Services Organization (MSSO) and the Japanese Maintenance Organization (JMO) reported on the growth of their subscriber bases. The number of subscribing organizations to MedDRA is now over 5,000 in 103 countries. This reflects the successful adoption of MedDRA as a worldwide standard in the protection of public health. Future areas of focus for the MSSO include continuing to support the global use of MedDRA and exploring interoperability between MedDRA and other medical terminologies.

Coordination with the WHO Collaborating Centre for International Drug Monitoring

The Board noted that the MSSO and the WHO Collaborating Centre for International Drug Monitoring (Uppsala Monitoring Centre) held their first joint MedDRA and WHODrug User Group meetings in Bangalore and Mumbai, India in February 2017. Following this succcessful collaboration, another joint MedDRA/WHODrug meeting is planned for Beijing, China in September 2017.

ICH M1 Points to Consider

The Board noted the efforts of the ICH M1 Points to Consider (PtC) Working Group in supporting MedDRA’s global uptake. The Working Group has developed condensed versions of the PtC documents for translation into all MedDRA languages (English and Japanese versions 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 noted that the Working Group has begun development of a companion document to the PtC documents, available in English and Japanese. This document will provide more detailed guidance, examples, and “Questions and Answers” on topics of regulatory importance such as data quality and medication errors. The first edition of the companion document is expected to be available in 2018.

Software Tools

The MSSO reported that the MedDRA Self-Service Application was launched in April 2017. This web-based tool allows MedDRA users to retrieve subscription information and passwords, confirm the subscription status of business partners, and obtain certificates for attending face-to-face training classes.

Standardised MedDRA Queries (SMQs)

The Board acknowledged the significant work of the CIOMS SMQ Implementation Working Group (IWG) and noted that one new SMQ Infective pneumonia will go into production in September 2017 for MedDRA Version 20.1.

The Board was also updated on other important initiatives and developments. The MSSO reported on its participation in the Innovative Medicines Initiative’s WEB-RADR (Recognising Adverse Drug Reactions) project and the development of a draft set of “patient friendly terms” to support direct patient reporting through mobile applications and web portals.

The next scheduled meeting of the Board will be on 11-12 November 2017 in Geneva, Switzerland.

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: PressRelease@ich.org - Websites: www.ich.org / www.meddra.org

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