PMDA Symposium RE: Phase 1 Trial Inclusion Guidance

On August 4th the PMDA held an Online Symposium, addressing  the updated guidance of the implementation of Phase 1 trials in Japanese subjects prior to international joint trial inclusion.

There was a record of over 2,600 attendees, and mention of the contents of the symposium to be offered in an English version at a later date.

For those of you not fluent in Japanese but have an AI assistant handy to translate, you are welcome to see what is currently offered here:

「「海外で臨床開発が先行した医薬品の国際共同治験開始前の日本人での第Ⅰ相試験の実施に関する基本的考え方について」に関する公開シンポジウム」の開催について | 独立行政法人 医薬品医療機器総合機構

Otherwise, we hope to provide a link to the English information when it becomes available.

( Also mentioned on our LinkedIn account here .)