Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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REGULATORY
- PMD Amendment Bill Put under Continued Diet Review
June 28, 2019
- Chuikyo Reps Give Kudos to Formulary Initiatives, but Wary on Creating Medical Fees
June 27, 2019
- Chuikyo Raises No Objection to Earlier Price Cuts for LLPs, Payers Want Stricter Rule
June 27, 2019
- MHLW to Conduct Drug Price Survey before October Tax Hike: Chuikyo
June 27, 2019
- No Established Definition Is in Place for Formulary: Govt
June 27, 2019
- Janssen’s HIV Drug Symtuza to Join NHI Price List on July 3
June 27, 2019
- AMED Beats Target with Out-Licensing of 162 Drug Candidates in FY2015-FY2018
June 27, 2019
- Set Lower Premiums for Super Pricey Cell, Gene Therapies: Drug Pricing Organization
June 26, 2019
- Drug Pricing Organization Pitches Earlier Price Cuts for LLPs If AGs Launched, PMP Tweaks and More
June 26, 2019
- AMED to Fund Biomarker Development for Anti-PD-1 Antibodies
June 25, 2019
- Japan Cabinet Adopts 2019 Honebuto Policy, No Big Change Made on Drug Pricing
June 24, 2019
- Govt Earmarks 3 Billion Yen for AMED's Organ-on-Chip Project
June 21, 2019
- ICH to Discuss Use of RWD in Post-Marketing Safety Measures: Amsterdam Meeting
June 20, 2019
- MOF Panel Paper Reiterates Copay Raise for “Small-Risk” Disease Treatments
June 20, 2019
- MHLW Orders Label Revisions for Metformin, Blanket Contraindication for Patients with Severe Kidney Impairment
June 19, 2019
- Japan Approves Roche/Chugai’s Tumor-Agnostic Rozlytrek, Alnylam’s RNAi Drug and More
June 19, 2019
- LDP Inscribes AI Utilization for Drug Development in Honebuto Paper
June 19, 2019
- PMDA to Strengthen Grad/Mid-Career Hiring Strategy, Increase Operating Efficiency with AI
June 19, 2019
- 2 PMDA Advisors Infringe COI Rules; No Impact on Product Approvals
June 18, 2019
- PMDA to Prohibit Staffers from Trading Pharma Shares
June 17, 2019
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International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement…
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…
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…