https://doi.org/10.4081/mem.2001.728
Storia della normativa italiana in materia di medicinali fino alle norme più recenti sulla valutazione bioetica della sperimentazione clinica
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Autori
Dopo un breve excursus storico dei provvedimenti normativi sui medicinali adottati nella Unione Europea e recepiti dall'Italia, vengono descritti gli sviluppi più recenti della normativa sulla valutazione bioetica della sperimentazione clinica (ossia della fase di sperimentazione del farmaco sui soggetti umani che succede alla fase di sperimentazione sull'animale). In particolare, l'Autrice prende in esame le Nuove Norme Europee di Good Clinical Practice (GCP) e le ricadute che hanno portato alla normativa emanata in Italia riguardo il "consenso informato" ed il ruolo dei Comitati Etici. Inoltre, sono illustrati gli ultimi provvedimenti della normativa italiana. Questo lavoro costituisce dunque una rassegna sull'argomento. Certamente, allo stato attuale in Italia sono stati realizzati molti progressi nella trasposizione della legislazione comunitaria in diritto nazionale soprattutto nel campo della sperimentazione sui soggetti umani in particolare ma, probabilmente, altro lavoro deve essere svolto per coprire più vaste necessità in molti altri campi della ricerca scientifica in generale.
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