The development of MedDRA was started in the late 1990s by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). MedDRA is a rich and highly specific standardised medical terminology to facilitate sharing of regulatory information internationally for medical products used by humans. MedDRA is made available by ICH 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.The ICH MedDRA Management Committee has overall responsibility for the direction of MedDRA development, and oversees all the activities of the ICH MedDRA Maintenance and Support Services Organization (MSSO) which is tasked to maintain, develop and distribute MedDRA.
