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Welcome to the June issue of RF Quarterly, which focuses on regulatory history and inlcudes articles on Japan’s Pharmaceuticals and Medical Devices Agency, medical device regulation in China, a personal reflection on the International Council for Harmonisation, and the histories of clinical trial disclosure requirements, expedited pathways, and the De Novo pathway and Final Rule.
1 Introduction Daniel Mannix, PhD, and Robert Falcone, PhD, FRAPS HTML 4 Evolution of the Japanese regulatory system and agencies Susumu Nozawa, RAC, FRAPS HTML 19 China’s NMPA: The evolution of medical device regulation Grace Palma, MBA, and Tina Zhao, PharmD HTML 35 The ICH over the last 30 years: A personal reflection David Jefferys, MD, FRAPS HTML 44 The history of clinical trial disclosure Thomas Wicks, MBA HTML 54 A history of expedited pathways: Breakthrough therapy designation, PRIME, Sakigake, and ILAP Maurice Bancsi, PhD HTML
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