HOME > BOARD > Bulletin

: 11

: GBC 2024 : Fri, 27 September, 1:02 PM

[Q&A] Day 2 Global Clinical Trial Regulatory Authorities Forum

Day 2 (Sep 5) Global Clinical Trial Regulatory Authorities Forum Q&A

Please refer to the table below.


Speaker: Junko Sato (PMDA)

Q1

There was information about allowing approval documents in English, and I wonder if there are plans to expand this area to other areas such as biosimilars as well as innovative drugs.

A1

Accepting application documents in English is a pilot program. It has been just started in this month. At this stage, it is only for companies that do not have affiliates in Japan developing innovative pharmaceuticals.

 
Attachments
Back to list
Comments 0
  • There are no comments here.