The International Conference on Harmonisation has agreed upon the structure and content of the Medical Dictionary for Regulatory Activities (MedDRA version 2.0 which should become available in the early part of 1999, This medical terminology is intended for use in the pre-and postmarketing phases of the medicines regulatory process, covering diagnoses, symptoms and signs, adverse drug reactions and therapeutic indications, the names and qualitative results of investigations, surgical and medical procedures, and medical/social history.
It can he used for recording adverse events and medical history in clinical trials, in the analysis and tabulations of data from these trials and in the expedited submission of safety data to government regulatory authorities, as well as in constructing standard product information and documentation for applications for marketing authorisation.
After licensing of a medicine, it may be used in pharmacovigilance and is expected to be the preferred terminology for international electronic regulatory communication.
MedDRA is a hierarchical terminology with 5 levels and is multiaxial : terms may exist in more than 1 vertical axis, providing specificity of terms for data entry and flexibility in data retrieval.
Terms in MedDRA were derived from several sources including the WHO's adverse reaction terminology (WHO-ART). (...)
Mots-clés Pascal : Terminologie, Médecine, Langage médical, Essai clinique, Autorisation mise sur marché, Harmonisation, Réglementation professionnelle, Industrie pharmaceutique, Recherche développement
Mots-clés Pascal anglais : Terminology, Medicine, Medical language, Clinical trial, Marketing authorization, Harmonization, Professional code, Pharmaceutical industry, Research and development
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 99-0171195
Code Inist : 002B30A09. Création : 16/11/1999.