Australasia / C.T. Hung [and others] -- Brazil / Margareth R.C. Marques, Sílvia Storpirtis, and Márcia Martini Bueno -- Canada / Iain J. McGilveray -- The European Union / Roger K. Verbeeck and Joelle Warlin -- India / Subhash C. Mandal and S. Ravisankar -- Japan / Juichi Riku -- South Africa / Isadore Kanfer, Roderick B. Walker, and Michael F. Skinner -- South America and Pan American Health Organization / Silvia Susana Giarcovich and Ricardo Bolaños -- Taiwan / Li-Heng Pao, Jo-Feng Chi, and Oliver Yoa-Pu Hu -- Turkey / Ilker Kanzik and A. Atilla Hincal -- United States of America / Barbara M. Davit and Dale P. Connor -- The World Health Organization / John Gordon [and others]
Summary
Discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products