POINTS-OF-VIEW ON ADVERSE DRUG-REACTIONS TERMINOLOGY

Global management of drug safety data is the best way to make the dete ction and validation of adverse drug reactions (ADRs) earlier. Central ization needs a previous standardization, of which terminology is a cr ucial component. ADR terminology must he designed so as to enable user s to know exactly what is covered by each term regarding the nature of the reaction and its significance for public health. A worldwide stan dardized terminology for all drug reporting purposes is currently bein g developed by the International Conference on Harmonization of Techni cal Requirements for Registration of Pharmaceuticals for Human Use. Ho wever, practical definitions of medical terms will be necessary and co uld be developed by specialists on drug safety in collaboration with s pecialists of different system organs, as has already been achieved fo r some of them.