(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

The words and actions of US President Donald Trump are rocking the pharmaceutical industry. On May 5, he said he…

The traditional HR Business Partner (HRBP) model, once the gold standard for HR delivery, is undergoing a significant transformation. Many organizations, particularly in industries like pharmaceuticals, are moving towards a more agile resource model, aiming to streamline HR operations and…

The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…

Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…

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…

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

The Ministry of Health, Labor and Welfare (MHLW) posted the final report compiled by its pharmaceutical regulation panel on its website on April 24, providing cases of drugs that could be exempted from all-case post marketing surveillance (PMS).The MHLW plans…

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…