Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
REGULATORY
MHLW Seeks Comments on Rx-to-OTC Switch of Tadalafil, 2 Other APIs
The Ministry of Health, Labor and Welfare (MHLW) on November 25 started inviting public opinions on the Rx-to-nonprescription switching of the erectile dysfunction treatment tadalafil (brand name: Cialis) and two other APIs. The three APIs are the first batch of…
To read the full story
Related Article
- SSP to Roll Out Pharmacist Training Ahead of OTC Cialis Launch in Japan
October 1, 2025
- MHLW Panel Endorses Rx-to-OTC Switch of Tadalafil in Japan
September 22, 2025
- SSP Files for OTC Switch of Tadalafil in Japan
June 10, 2025
- MHLW Panel Wary of Non-Prescription Switches for Diquas, Mucosta
February 13, 2025
REGULATORY
- Japan Govt Council Discusses Draft Recommendations for National MCM Strategy
December 9, 2025
- MHLW Eyes Govt-Led Ingredient Lists for Regional Formularies: LDP Briefing
December 9, 2025
- JMA Pushes Back on Incentives Tied to Regional Formularies: Chuikyo
December 9, 2025
- PMDA to Adopt General-Purpose AI in FY2025, Eyes Specialized Tools for Reviews and Safety Work
December 8, 2025
- Japan Likely to Extend Generic-Name Prescribing Premium to Biologics to Spur Biosimilars
December 8, 2025
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…
As Japan approaches the Fiscal System Council’s “autumn recommendation,” a notable shift is taking shape. The Ministry of Finance (MOF),…
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…