Integrate Japan Into Global Clinical Development
JAPAN REGULATORY DEVELOPMENT STRATEGY AND PMDA CONSULTATION FOR US-BASED ONCOLOGY COMPANY
THE PROBLEm
The company has already reached an agreement with the FDA and EMA with regard to global clinical trials for oncology treatment. In order to develop its product in Japan as well, the company has reached out to Yakumed for advice and support on the most suitable approach to develop its product in Japan.
THE SOLUTION
Yakumed has put together an in-depth independent assessment analysis highlighting the path forward in Japan and the potential risks. Yakumed has also led the preparation for PMDA consultation, and the negotiation with PMDA, and along the way, Yakumed has provided valuable advice (on the strategic and tactical levels) to ensure a positive outcome in PMDA consultation meetings. The interaction with PMDA through Yakumed has been very positive and it helped Japan to join the global clinical study.