LEXICON
No.81 September 12, 2011

Marketing authorization holder
製造販売業者
Manufacturing/manufacturer
製造(元)
Sales, distribution/distributor
販売(元)
Marketing/marketer (marketing authorization holder)
発売(元)
Promotion
販促

The amended Pharmaceutical Affairs Law (PAL;薬事法), which went into effect in April 2005, has introduced a new marketing business licensing system (製造販売業の許可体系) and has changed the conventional manufacturing approval system (製造承認制度) to the new marketing approval system (製造販売承認制度). Under the...

To read the full story

LEXICON

By Philip Carrigan

Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…

By Ken Yoshino

As Japan approaches the Fiscal System Council’s “autumn recommendation,” a notable shift is taking shape. The Ministry of Finance (MOF),…

Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…

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…