MedDRA: Background information

MedDRA

In the late 1990s, the International Conference on Harmonisation of Technical Requirements for Registration of 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.

ICH has created a governance structure to nurture and protect the integrity of MedDRA. The ICH MedDRA Management Board, appointed by the ICH Steering Committee, has overall responsibility for the direction of MedDRA, and oversees all the activities of the ICH MedDRA Maintenance and Support Services Organization (MSSO) which is tasked to maintain, develop and distribute MedDRA. ICH has also established a Japanese Maintenance Organization (JMO), which works in close collaboration with MSSO, to support users in Japan.

Article 25 of the Commission Implementing Regulation (EU) No 520/2012 requires Member States, marketing authorisation holders and the Agency to apply the MedDRA terminology for the classification, retrieval, presentation, risk-benefit evaluation and assessment, electronic exchange and communication of pharmacovigilance and medicinal product information.

More information about MedDRA and how to subscribe

Further information can be obtained on the following website: http://www.ich.org/products/meddra.html

To obtain a MedDRA license please refer to the following website: http://www.meddra.org/subscription/process

For any specific questions related to EudraVigilance, please contact the EMA as follows:

• For technical support, visit the EMA Service Desk portal: https://servicedesk.ema.europa.eu
• For urgent technical matters, telephone: +44 (0)20 3660 8520
• EudraVigilance web site: http://eudravigilance.ema.europa.eu
  

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Last update: Wednesday, 6 July 2016.