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
MHLW Regulatory Panel OKs New Procedures for Post-Approval Manufacturing Changes
A health ministry study group on pharmaceutical regulations on October 13 roughly agreed on a reform plan for Japanese regulatory procedures pertaining to post-approval changes in manufacturing methods and quality control - a move aimed at harmonizing the process with…
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