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REGULATORY
- Proper Use of Ethical Moisturizing Agents Added to Supplementary Opinion for FY2018 Reimbursement Reform: Chuikyo
February 1, 2018
- Drug Pricing Reform Draws Mixed Opinions: Public Comments
February 1, 2018
- Drug Makers Looking to Adopt Continuous Manufacturing, Anticipating 30-40% Lower Production Costs: PMDA Official
January 31, 2018
- MHLW to Create Framework for Announcing Results of Clinical Research in Tandem with Enforcement of Clinical Research Law
January 29, 2018
- Chuikyo to Continue Discussions on Drug Pricing Reform “After Verifying Impact on Stakeholders”; Further Discussions on Essential Drugs
January 29, 2018
- Chuikyo Discusses Hirudoid, Gx at 2nd Review Round for FY2018 Fee Schedule Revision
January 29, 2018
- MHLW Panel Backs Novo’s Semaglutide after Recommendation Hold
January 29, 2018
- MHLW’s Drug Distribution Guidelines Issued for Enforcement in April
January 26, 2018
- MHLW Reiterates Caution over Tagrisso Use after Opdivo Treatment
January 26, 2018
- IPRP to Hold First Meeting in June in Japan, May Take up Harmonization of Regulations on Regenerative Medicine Products
January 26, 2018
- Chuikyo Enters Final Review of FY2018 Fee Schedule Revision; Recommendation Due Out Feb. 7
January 25, 2018
- MHLW to Launch New Project to Strengthen Generic Drug Use in Around 10 “Priority Prefectures” Aiming at 80% Volume Share Target
January 25, 2018
- Japan Govt to Halt R&D Tax Break for Small Spender Companies: PM Abe
January 24, 2018
- Eligibility for Conditional Early Approval “Will Not Be Restricted to Orphan Drugs”: MHLW
January 24, 2018
- Japan’s 1st Herceptin Biosimilar Likely to Be OK’ed by March for Gastric Cancer
January 23, 2018
- Shionogi’s Sakigake-Designated Flu Med Up for MHLW Panel Review on Feb. 2, Early Listing Possible?
January 23, 2018
- Cooperation from Govt, Insurers to Meet 80% Generic Target, Control of Long-Term Prescriptions Requested: Chuikyo Public Hearings
January 22, 2018
- MHLW OKs Dupixent, Tecentriq, Lynparza, and More
January 22, 2018
- PMDA to Promote Simplification of Documentation Required in Applications, Acceptance of Documents in Electronic Form
January 19, 2018
- Chuikyo OKs New Drug Pricing Rules for FY2018 Reform
January 18, 2018
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As Japan’s budget season draws near, the Ministry of Finance (MOF) has renewed its push for a full-scale “off-year” drug…
Japan is pressing ahead with broader drug price cuts under its cost-effectiveness assessment (CEA) system, despite lingering questions over the…
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Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…