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 Maintenance and Support Services Organization (MSSO), contracted by ICH, is tasked to maintain, develop and distribute MedDRA. A Japanese Maintenance Organization (JMO) has also established to support users in Japan. 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 Steering Committee, MedDRA is continuously enhanced to meet the evolving needs of regulators and industry around the world. The 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. In addition, since 2017, the remit of the M1 PtC WG was extended to include the development and the maintenance of a companion document to the PtC documents, which provides additional details, examples, and guidance on specific MedDRA related topics of global regulatory importance.
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. Other translations will be considered, should interest be expressed to the MedDRA Steering Committee.
Collaboration with international organisations:
Collaboration with international organisations is ongoing, with continued efforts to maintain and develop mappings between MedDRA and other terminologies.