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. Also, it is the adverse event classification dictionary. 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. In MedDRA version 25.0, Swedish and Latvian translations were also added. 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; Health Canada, Canada; MHLW/PMDA, Japan; Swissmedic, Switzerland; and TFDA, Taipei. Information about the implementation status of MedDRA by ICH Regulatory Members is updated by ICH on its website. MedDRA is widely used internationally, with close to 7,500 subscribing organizations in almost 130 countries. Each organization, regardless of its number of users, requires only one subscription to MedDRA. MedDRA Vision 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. As 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. The single standardized terminology offers several clear advantages for regulators, industry, and other stakeholders: 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; Improvements in the ease, quality, and timeliness of data available for effective analysis, exchange, and decision making; Consistency of the terminology throughout the different stages of the development of a medicinal product allowing effective cross-references and analysis of data; Facilitation of the electronic exchange of data relating to medicinal