(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

Japan’s key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…

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…

Takeda Pharmaceutical’s overseas sales ratio has reached 90.9%, exceeding 90% for the first time though only in the first half…

In a recent conversation with James Feliciano, former president of AbbVie Japan, we delved into the intricacies of leadership in the Japanese pharmaceutical industry. Feliciano, a seasoned industry veteran, shared valuable insights into his experiences, challenges, and successes.Navigating the Abbott…

A Japanese health ministry panel on November 28 agreed on a plan to legally require pharma companies to set up…

Eli Lilly’s Kisunla (donanemab) will join the Japanese reimbursement list on November 20, with a health ministry panel giving 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…