The policy change is expected to lower barriers for foreign pharmaceutical companies, making their new drugs accessible in Japan as soon as possible.
The Ministry of Health, Labor and Welfare says this is intended to ensure safety for people living under the conditions found in Japan.
In order to improve the situation, the health ministry will soon issue a new notice stating that additional testing of Japanese nationals is not required in principle.
The ministry has decided that the safety of drugs in Japanese patients can be confirmed in Phase 3 even if earlier additional studies are eliminated.
In response to the health ministry’s hearing, one pharmaceutical company commented, “Clinical trials for Japanese patients are a barrier to introducing new drugs.”
A Western pharmaceutical company also noted, “The necessity of [additional testing] is not fully explained, and our headquarters does not understand it.”
The original article contains 558 words, the summary contains 143 words. Saved 74%. I’m a bot and I’m open source!
This is the best summary I could come up with:
The policy change is expected to lower barriers for foreign pharmaceutical companies, making their new drugs accessible in Japan as soon as possible.
The Ministry of Health, Labor and Welfare says this is intended to ensure safety for people living under the conditions found in Japan.
In order to improve the situation, the health ministry will soon issue a new notice stating that additional testing of Japanese nationals is not required in principle.
The ministry has decided that the safety of drugs in Japanese patients can be confirmed in Phase 3 even if earlier additional studies are eliminated.
In response to the health ministry’s hearing, one pharmaceutical company commented, “Clinical trials for Japanese patients are a barrier to introducing new drugs.”
A Western pharmaceutical company also noted, “The necessity of [additional testing] is not fully explained, and our headquarters does not understand it.”
The original article contains 558 words, the summary contains 143 words. Saved 74%. I’m a bot and I’m open source!