A total of 43 innovative new medicines are anticipated to be approved or listed in Japan this year, according to a survey by Jiho. At the center of attention are some highly innovative, but probably ultra-expensive, gene therapies, as well…
REGULATORY
One-Month Lag in Regulatory Filing Accepted for Sakigake Designation
The Ministry of Health, Labor and Welfare (MHLW) will consider products for designation under the so-called “sakigake” fast-track review system as long as their regulatory filing in Japan is within one month of their first application submission elsewhere in the…
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