Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
HOME > REGULATORY
REGULATORY
- MHLW Revises GCP Ordinance to Incorporate New Compassionate Use Scheme
January 26, 2016
- Govt Panel Says New Growth Strategy Should Embrace Further Efforts to Fuel Drug Development
January 26, 2016
- PAFSC First Committee to Discuss Add’l Indications for Rituxan, Cymbalta on Feb. 5
January 26, 2016
- Japan Compassionate Use Gets Underway Covering Sakigake-Requested Products, Orphans
January 26, 2016
- MHLW OKs Japan’s First PCSK9 Inhibitor, Other Drugs
January 25, 2016
- Gilead’s 2 Hep C Drugs Likely to Face Some 30% Price Cut under “Huge Seller” Re-Pricing: Jiho Estimate
January 25, 2016
- Sakigake Review System to Shorten Review Time through Greater Efficiency, Not Simplification: Mr Kono of PMDA
January 25, 2016
- PMDA Reviewing Nexium for Risk of Rhabdomyolysis
January 25, 2016
- MHLW Panel on Blood Programs Approves 950,000-Liter Acquisition Target for Raw Plasma in FY2016
January 22, 2016
- Bill Payer Proposes “Penalties through NHI Prices” for Violations of Pharma Law in Wake of Kaketsuken Scandal: Chuikyo
January 22, 2016
- 4 Listed Drugs plus Similar Products Subject to Cost-Effectiveness Review: Chuikyo
January 21, 2016
- Chuikyo OKs New Drug Pricing Rules for FY2016 Reform; Sakigake-Designated Add’l Indications Also Subject to Premiums
January 21, 2016
- MHLW to Designate 617 Products/134 APIs as “Essential Drugs”: Will Receive Uniform, Stable NHI Prices, Exempt from Z2 Rule
January 21, 2016
- “Huge Seller” Re-Pricing to Hit Sovaldi, 3 Other Brands; Hefty 20 APIs Face Regular Market Expansion Re-Pricing
January 21, 2016
- Need of Placebo-Controlled Studies Will Be Decided on Case-by-Case Basis: PMDA Official
January 20, 2016
- Seriousness of Target Diseases, Efficacy Became Key in Sakigake Designation: MHLW Official
January 20, 2016
- Drug Makers Told to Check Conformity of Manufacturing Process with Approved Methods
January 20, 2016
- PAFSC’s 2nd Committee to Review Novartis’s Melanoma Drugs on Feb. 1
January 20, 2016
- “Huge Seller” Re-Pricing to Hit Sovaldi, Harvoni, Avastin, Plavix
January 20, 2016
- Discussions on Market Price Survey for 2017 Revision Likely to Begin in March, Conclusion Expected in June
January 19, 2016
ページ
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
Adeno-associated virus (AAV) gene therapies have long been viewed as carrying only a minimal risk of insertional mutagenesis — a…
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…