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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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