(New drug application (NDA)) Review report

審査報告書

Report on the deliberation results

審議結果報告書

Clinical trial (study) report

治験総括報告書

Summary technical documentation (STED)

申請資料概要

Application for marketing approval; new drug application (NDA)

製造販売承認申請書

Application dossier

申請資料

Summary basis of approval (SBA)

新医薬品承認審査概要

As CEO of Morunda, I had the privilege of interviewing Bill Schuster, Country Manager of Viatris in South Korea. Our conversation delved into the multifaceted nature of leadership in the healthcare industry, exploring challenges, successes, and the power of authenticity.A…

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…

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For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…

A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…

A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…

Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…

The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…