MedDRA: Medical Dictionary for Regulatory Activities
In the late 1990s, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) developed MedDRA, a rich and highly specific standardised medical terminology to facilitate sharing of regulatory information internationally for medical products used by humans. ICH’s powerful tool, MedDRA is available to all for use in the registration, documentation and safety monitoring of medical products both before and after a product has been authorised for sale. Products covered by the scope of MedDRA include pharmaceuticals, biologics, vaccines and drug-device combination products. Today, its growing use worldwide by regulatory authorities, pharmaceutical companies, clinical research organisations and health care professionals allows better global protection of patient health.
In addition to the original English master and Japanese translation, MedDRA has been translated and is maintained in the following languages: Chinese, Czech, Dutch, French, German, Hungarian, Italian, Korean, Portuguese, Portuguese - Brazilian, Russian, and Spanish. Each MedDRA term has an associated 8-digit numerical code which remains the same irrespective of the language. Multiple languages allow a wide number of users to operate in their native language which promotes accuracy and precision in assigning codes. This interoperability is very powerful and allows easy sharing of data internationally.