Approaching China's Pharmaceutical Market, Softcover reprint of the original 1st ed. 2015 A Fundamental Guide to Clinical Drug Development
Coordonnateur : Lu Ming Q.
Preface.- Law, Regulation and Guidance.- Pharmaceutical Intellectual Property Rights in China.- The China Food and Drug Administration (CFDA).- Registration.- Guidance for Application Materials/Booklets (Chemical).- New Investigational Drug Application.- Clinical Development of Investigational New Drug.- Strategic Drug Development in China and Surrounding Countries.- Drug Safety Monitoring and Reporting Systems in China.- In Vitro Diagnostic Development.- Index.
Addresses the key issues for multinational pharmaceutical companies looking to market their drugs in China
Highlights the regulations of the Chinese State Food and Drug Administration (SFDA) and the Center for Drug Evaluation of the SFDA (CDE)
Serves as a fundamental guide for clinical research, regulatory, quality control/assurance, and legal departments
Includes supplementary material: sn.pub/extras
Date de parution : 10-2016
Ouvrage de 648 p.
15.5x23.5 cm
Disponible chez l'éditeur (délai d'approvisionnement : 15 jours).
Prix indicatif 158,24 €
Ajouter au panierDate de parution : 08-2015
Ouvrage de 648 p.
15.5x23.5 cm
Disponible chez l'éditeur (délai d'approvisionnement : 15 jours).
Prix indicatif 158,24 €
Ajouter au panierThèmes d’Approaching China's Pharmaceutical Market :
Mots-clés :
CFDA; FDA; drug management law; investigational drug; regulatory guidance