MedDRA meaning in Governmental ?

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 also translated into Chinese, Czech, Dutch, French, German, Hungarian, Italian, Korean, Portuguese, Brazilian Portuguese, Russian, and Spanish.

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, Chinese 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 more than 6,800 subscribing organizations from over 125 countries.Each organization, regardless of its number of users, requires only one subscription to MedDRA.