The medical dictionary for drug regulatory affairs (MEDDRA) project
- 1 January 1994
- journal article
- research article
- Published by Wiley in Pharmacoepidemiology and Drug Safety
- Vol. 3 (1) , 7-13
- https://doi.org/10.1002/pds.2630030105
Abstract
Electronic transmission of information is a key component of the Future System for medicines regulation in the European Union (EU). Data sets and terminology will have to be standardized in order to ensure effective information exchange between organizations. The Medical Dictionary for Drug Regulatory Affairs (MEDDRA) is a medical terminology being prepared by an international Working Party for use by regulatory authorities, pharmaceutical companies and other relevant organizations. It incorporates terms relevant to all areas of drug regulation, including the marketing authorization (MA) process, MA maintenance/renewal and pharmacovigilance.Keywords
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