The MHLW’s proposed 2024 budget will increase about 12%. Part of this increase will be used to set up a new regulatory consultation group which will focus on expediting pediatric and orphan drugs. This group will also help the MHLW committee in reviewing drugs not approved in Japan yet, etc. The MHLW has also allocated additional money to help Japan clear the way for more engagement with multi-regional clinical studies by lowering Japan’s clinical trial expenses and related bureaucratic systems. The MHLW plans to set up new clinical trial guidelines and streamline processes. In addition, in an effort to expedite regenerative medicine in Japan, the MHLW will set up a “regenerative medical interpreter” in the PMDA to provide expertise on regenerative medicine clinical trials, product registration, etc.
The above effort will hopefully help Japan with its drug lag problem. In addition, the new PMDA office in the US will open in 2024 and this will provide more Japanese regulatory guidance to increase Western drug and biotech companies’ interest in going to Japan.