ORGANIZATION

JPMA Regulatory Chief Seeks Balanced Approach on Japanese PI Waivers

By Ken Yoshino September 3, 2025
Yuji Kashitani, chair of the Regulatory Affairs Committee at the Japan Pharmaceutical Manufacturers Association (JPMA), has cautioned that Japan’s recent shift toward waiving Japanese PI trials should not be misunderstood as making them unnecessary in all cases. “There is a…

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