Japan Drug Registration Continues to Improve

The Japanese government is very aware that many drugs approved in the West are not approved in Japan. The issue of drug lag in Japan is significant as it deprives Japanese citizens of access to the same cutting-edge pharmaceuticals that benefit people elsewhere in the world. Thus, the Japanese government has started a number of initiatives to make things better and reduce the lag.

First, last year, the MHLW set up a new group to study this drug lag problem and make suggestions on how to fix these issues. Topics discussed include issues about whether Japanese patient data are always required for drug approvals, how to have more effective clinical trials, etc.

Second, the MHLW will grow its budget for drug approvals in 2024 by 12%. The increased funding will also be used to set up a new registration consultation group to examine drugs approved overseas but not approved in Japan. Some of this money will be allocated to developing more orphan drugs, pediatric drugs, and regenerative medicine products.

Third, the MHLW will not always require Phase 1 studies to be done in Japan in advance of late-stage global clinical studies. This should help expedite drug approvals in Japan.

Fourth, while drug registrations normally require clinical trials in Japan done according to Japanese GCP requirements, in some situations the Japanese government is going to allow Specified Clinical Research which is regulated by different standards – to be used for drug approvals.

Fifth, with respect to fast-track approvals via the Sakigake system, the MHLW requires that drugs be filed in Japan first or filed within 30 days of submission in the West. Now, the MHLW has increased the time for the drug to be filed in Japan from 30 days to 90 days of submission in the West.

Sixth, for more innovative drugs, the PMDA will offer more consultation services than before. Such sessions will give earlier feedback to the applicants including alerting them when data are not complete, determine clinical trial requirements quicker, etc.

Finally, in an effort to help overseas biotech and drug companies to better understand the Japanese drug registration process, the PMDA is going to set up an overseas office in the US and Asia. This will be the first time the PMDA has done this.