LEXICON
No.105 March 12, 2012

Drug marketing license (authorization) holder; drug marketer
医薬品製造販売業者
First-class drug marketing license (authorization) holder; first-class drug marketer
第1種医薬品製造販売業者
Second-class drug marketing license (authorization) holder; second-class drug marketer
第2種医薬品製造販売業者

The Pharmaceutical Affairs Law (PAL;薬事法) which went into effect in April 2005 separated drug manufacturing (製造) from marketing (製造販売), allowing companies without their own manufacturing facilities (製造設備) to market drugs manufactured by other companies (manufacturing license holders;製造業者). Drug marketing license...

To read the full story

LEXICON

Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…

By Tatsuya Otsuka

Japan is ramping up its push to spread regional formularies nationwide, a policy expected to standardize treatments, strengthen supply resilience,…

By Philip Carrigan

We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…

Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…

By Ken Yoshino

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…