MedDRA

Medical Dictionary for Regulatory Activities

MedDRA 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. Products covered by the scope of MedDRA include pharmaceuticals, vaccines and drug-device combination products.

MedDRA is open to anyone who would like to use it, although on its initial implementation in 1999, most users were based in Europe, Japan and USA.  Today, its growing use worldwide by regulatory authorities, global pharmaceutical companies, clinical research organisations and health care professionals, allows better global protection of patient health.

The MSSO (Maintenance and Support Services Organization), contracted by ICH with technical and financial oversight by the MedDRA Management Committee, is tasked to maintain, develop and distribute MedDRA. The terminology is free for all regulators worldwide, academics, health care providers and others involved in non-commercial activities while paid subscriptions are on a sliding scale linked to annual turnover of companies.

Under the governance of the MedDRA Management Committee, MedDRA is continuously enhanced to meet the evolving needs of regulators and industry around the world.  The current ICH M1 Points to Consider Working Group develops and maintains two documents on the use of MedDRA for data entry (coding) and data retrieval/analysis. The latter includes guidance on the use of SMQs, Standardised MedDRA Queries, as powerful tools for assisting with safety signal detection. Both documents are updated once a year, with the March release of MedDRA.

To further facilitate its implementation and correct use, free training is offered and MedDRA is available today in a number of translations of the original English version – Chinese, Czech, Dutch, French, German, Hungarian, Italian, Japanese, Korean, Portuguese, Brazilian Portuguese, Russian and Spanish.  Other translations will be considered, should interest be expressed to the MedDRA Management Committee. 

Collaboration ICH and WHO:

MedDRA is fully implemented in the WHO global safety database allowing entry and retrieval of information in either MedDRA or WHO-ART.  A mapping bridge is kept updated by WHO and ICH, to allow conversion of WHO-ART coded data into MedDRA, allowing users to readily convert their data and use MedDRA.