M1 MedDRA Terminology
M1 MedDRA - Medical Dictionary for Regulatory Activities
The development of a Medical Dictionary for Regulatory Activities (MedDRA) was approved by the ICH Steering Committee in 1997, and the terminology was launched in 1999. Due to the development of this topic over the years, all information about MedDRA and the Points to Consider documents developed for every MedDRA version are available on the MedDRA page of the ICH website. Please also visit the official MedDRA website.
Date of Step 4: 1 January 1999
Status: Step 5
MedDRA
Medical Dictionary for Regulatory Activities
MedDRA is a rich and highly specific standardized 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 authorized 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 organizations 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, and health care providers 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, Standardized MedDRA Queries, as powerful tools for assisting with safety signal detection. Both documents are updated twice a year, with every MedDRA release.
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.
M1 PtC WG MedDRA Points to Consider
The MedDRA (Medical Dictionary for Regulatory Activities) terminology was launched in 1999.
To support the use of MedDRA, the M1 PtC WG updates with each MedDRA release the two Points to Consider (PtC) documents on MedDRA Term Selection and MedDRA Data Retrieval and Presentation, available in English and Japanese, as well as condensed versions available in all MedDRA languages.
Please refer to the MedDRA page and MedDRA website for information about MedDRA and the Points to Consider documents.
In addition, since 2017, the remit of the M1 PtC WG was extended to include the maintenance of a companion document to the PtC documents, available in English and Japanese, which provides more detailed guidance, examples, and Questions and Answers on topics of regulatory importance such as data quality, medication errors, and product quality issues.
Endorsed Documents (Click the links below for complete guidelines)
*These Guidelines Belongs to ICH website.
