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
Kaketsuken Suspends Shipments of 12 Products Due to Modifications of Approved Manufacturing Procedures
The Ministry of Health, Labor and Welfare (MHLW) announced on June 5 that 12 plasma pheresis products manufactured by the Chemo-Sero-Therapeutic Research Institute (Kaketsuken) from blood donated in Japan were manufactured using methods that differ from those approved. According to…
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