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2022 RF Quarterly Q2

RF Quarterly,  June 2022:
Regulatory history

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.

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Table of Contents

1    Introduction
          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

60  The evolution of the De Novo pathway
           Waleed Shabana, BA, and Tahir Rizvi, MEng


Upcoming in RF Quarterly  
  • Strategy in regulatory affairs (September 2022)
  • Artificial intelligence (December 2022)
Previous issues
Access more benefits in the former Article Series  on the following topics:
  • Regulatory Intelligence
  • The Shifting Global Regulatory Landscape
  • Global Regulatory Strategies and Best Practices
  • The Strategic Role of the Regulatory Professional
  • Risk Management and Quality
  • Global Strategies for Drugs and Devices
  • Executive Leadership and Management
  • Global Regulatory Policy and Strategy
To contribute, email Renee Matthews, Senior Editor, at rmatthews@raps.org. For more information, see Guidelines for Authors and the 2022 Editorial Calendar.

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