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The medical dictionary for drug regulatory affairs (MEDDRA) project
Author(s) -
Wood K. L.
Publication year - 1994
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.2630030105
Subject(s) - meddra , pharmacovigilance , terminology , marketing authorization , medicine , european union , authorization , regulatory affairs , directive , key (lock) , data exchange , drug , business , pharmacology , database , public administration , computer science , computer security , political science , bioinformatics , linguistics , philosophy , biology , programming language , economic policy
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 M edical D ictionary for D rug R egulatory A ffairs (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.