Japan’s New Fast Track Pathway for Drugmakers

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Japan’s New Fast Track
Pathway for Drugmakers

Japan is encouraging pharmaceutical companies to get new products approved first there, or at the very least, parallel to the US and EU, with it’s new “Sakigake” expedited pathway. Started in April 2015, the pathway is similar to the FDA’s breakthrough designation — potentially cutting approval time in half.

With this management report you will learn:

  • How to submit an NDA in Japan and get it approved using the new pathway
  • Strategic considerations for how you develop a drug in Japan
  • How to work best with Japan’s Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA)
  • What clinical trial notification entails in Japan
  • How to conduct a gap analysis of existing sponsor documentation compared with the applicable Japanese regulatory and medical requirements

If you’re going to bring your drugs to this massive market, you need this information to prepare for its unique challenges.


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Table of Contents

  • Introduction
  • Closing the Gap
  • Taking Advantage of the New Sakigake Pathway
  • Other Opportunities for Accelerated Review
  • And More …

View the entire TOC

Who Will Benefit

  • Executive management
  • General/corporate counsel
  • Managers
  • Manufacturing directors and supervisors
  • Personnel new to the industry
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Sales/marketing personnel
  • Strategic planning and business development staff
  • Training personnel

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