First class medical devices marketing license第一種医療機器製造販売業許可
To read the full story
LEXICON
-
Elective Care Scheme for LLPs長期収載品 選定療養制度July 19, 2024
-
G1/G2 RuleG1/G2ルールMarch 9, 2018
-
New PMP Criteria新薬創出加算の新要件March 9, 2018
-
Cost-Based Method原価計算方式July 27, 2017
-
Sakigake Designation Scheme先駆け審査指定制度August 17, 2016
Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
Following Hisamitsu Pharmaceutical’s decision to go private through a roughly 400 billion yen management buyout (MBO), industry observers are weighing…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
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 all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…