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
Panel OKs Withdrawal Rule for Conditional Nod, 2-Year Extension for Pediatric Data Protection towards PMD Act Amendment
A Japanese health ministry panel on October 3 endorsed a list of seven proposals related to regulatory reviews towards the next amendment of the Pharmaceuticals and Medical Devices (PMD) Act. At the centerpiece of the plans are measures to facilitate…
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