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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.
Daniel Mannix, PhD, and Robert Falcone, PhD, FRAPS
4 Evolution of the Japanese regulatory system and agencies
Susumu Nozawa, RAC, FRAPS
19 China’s NMPA: The evolution of medical device regulation
Grace Palma, MBA, and Tina Zhao, PharmD
35 The ICH over the last 30 years: A personal reflection
David Jefferys, MD, FRAPS
44 The history of clinical trial disclosure
Thomas Wicks, MBA
54 A history of expedited pathways: Breakthrough therapy designation,
PRIME, Sakigake, and ILAP
Maurice Bancsi, PhD
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