The MedDRA dictionary is organized with a five-level hierarchy. Facilitation of the electronic exchange of data relating to medicinal products.Consistency of the terminology throughout the different stages of the development of a medicinal product allowing effective cross-references and analysis of data.Improvements in the ease, quality, and timeliness of data available for effective analysis, exchange, and decision making.Removal of the need to convert data from one terminology to another preventing the loss and/or distortion of data and allowing savings in resources.The single standardized terminology offers several clear advantages for regulators, industry, and other stakeholders: Īs a result, MedDRA is designed for use in the registration, documentation, and safety monitoring of medicinal products through all phases of the development life cycle. In developing and continuously maintaining MedDRA, ICH endeavours to facilitate the exchange of clinical information through a single standardized international medical terminology that can be used for regulatory communication and evaluation of data pertaining to medicinal products for human use. MedDRA is widely used internationally, with more than 6,800 subscribing organizations from over 125 countries.Įach organization, regardless of its number of users, requires only one subscription to MedDRA. Information about the implementation status of MedDRA by ICH Regulatory Members is updated by ICH on its website. Many other industries, including tobacco and cosmetics, are also beginning to use MedDRA for capturing adverse health events.Īll Regulatory Members of ICH are expected to implement MedDRA within 5 years.Īs of 2020, the following ICH Regulatory Members have implemented MedDRA: EC, Europe FDA, United States HSA, Singapore Health Canada, Canada MHLW/ PMDA, Japan Swissmedic, Switzerland and TFDA, Chinese Taipei. In many countries/regions the use of MedDRA by biopharmaceutical companies is mandated for safety reporting. MedDRA is now also translated into Chinese, Czech, Dutch, French, German, Hungarian, Italian, Korean, Portuguese, Brazilian Portuguese, Russian, and Spanish. The first version of MedDRA was released in 1999 in English and Japanese. Also, it is the adverse event classification dictionary. JSTOR ( August 2011) ( Learn how and when to remove this template message)Ī 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.Unsourced material may be challenged and removed. Please help improve this article by adding citations to reliable sources. This article needs additional citations for verification.