LEXICON
No.83 September 26, 2011

GMP (Good Manufacturing Practice) (compliance) inspections
GMP(適合性)調査
GMP inspectors
GMP調査員
Sampling (samples); collection of samples
収去(品)

GMP (Good Manufacturing Practice) (compliance) inspections (GMP(適合性)調査) are conducted by GMP inspectors (GMP調査員) from the Pharmaceuticals and Medical Devices Agency (PMDA; 医薬品医療機器総合機構) or prefectural governments (都道府県). Domestic manufacturing facilities for new drugs (新医薬品), biopharmaceuticals (生物学的製剤), radiopharmaceuticals (放射性医薬品), products subject to...

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…