Global InformationMedDRA information
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A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary-thesaurus used by regulatory authorities and the biopharmaceutical industry during the regulatory process, from pre-marketing (clinical research phase 0 to phase 3) to post-marketing activities (pharmacovigilance or clinical research phase 4), and for safety information data entry, retrieval, evaluation, and presentation.[1] Also, it is the adverse event classification dictionary.[2]
The first version of MedDRA was released in 1999 in English and Japanese.
MedDRA is now translated into Chinese, Czech, Dutch, French, German, Hungarian, Italian, Korean, Portuguese, Brazilian Portuguese, Russian, and Spanish.[3] In MedDRA version 25.0, Swedish and Latvian translations were also added.[4]
In many countries/regions the use of MedDRA by biopharmaceutical companies is mandated for safety reporting. Many other industries, including tobacco and cosmetics, are also beginning to use MedDRA for capturing adverse health events.
All Regulatory Members of ICH are expected to implement MedDRA within 5 years.
As of 2020, the following ICH Regulatory Members have implemented MedDRA: EC, Europe; FDA, United States; HSA, Singapore;[5] Health Canada, Canada;[6] MHLW/PMDA, Japan; Swissmedic, Switzerland; and TFDA, Taiwan.[citation needed]
Information about the implementation status of MedDRA by ICH Regulatory Members is updated by ICH on its website.[7]
MedDRA is widely used internationally, with close to 7,500 subscribing organizations in almost 130 countries.[4] Each organization, regardless of its number of users, requires only one subscription to MedDRA.
- ^ Lenita Lindström-Gommers and Theresa Mullin "International Conference on Harmonization: Recent Reforms as a Driver of Global Regulatory Harmonization and Innovation in Medical Products"
- ^ Health Canada, Canada "About the Medical Dictionary for Regulatory Activities"
- ^ "Welcome to MedDRA".
- ^ a b "ICH Official web site : ICH". ich.org. Retrieved 2022-09-19.
- ^ "Adverse events reporting in clinical trials". HSA. Retrieved 2021-03-21.
- ^ Canada, Health (2010-11-16). "About the Medical Dictionary for Regulatory Activities". aem. Retrieved 2021-03-21.
- ^ M1 MedDRA Terminology Content is copied from this source, which is © ICH. It may be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICH's copyright is acknowledged.