For 25 years, Morunda has been interviewing leaders in Japan’s pharmaceutical and medical device industry. Most country managers typically come from a commercial background, rooted in sales and marketing. It’s rare to find country managers who come from finance or…
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REGULATORY
- 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
- Abe Vows to Work All-Out to Supervise Drug Manufacturers after Kaketsuken Oversight
January 19, 2016
- ICH-S9 Guideline to Apply to Non-Clinical Studies for “Serious Malignancies”
January 19, 2016
- New ICH Trial Guidelines to Embrace “Pooled Populations,” but PMDA Unlikely to Accept Zero Japanese
January 18, 2016
- MHLW Taskforce on Vaccines, Blood Products Kicks Off Discussions
January 15, 2016
- Research-Driven Makers Should Find Another Biz Model If They Can’t Innovate: Top Bureaucrat
January 15, 2016
- Fulminant Hepatitis to Be Added to List of Significant Adverse Reactions to Amlodipine Products
January 14, 2016
- AMED, US NIH Ink Memorandum of Cooperation for Orphan Diseases, Cancer
January 13, 2016
- Kaketsuken Ordered Record 110-Day Suspension, Shiozaki Says He Won’t Allow It to Remain As-Is
January 12, 2016
- Re-Pricing Rule for “Huge-Seller” Drugs Necessary Compromise to Protect Universal Healthcare While Promoting Innovation: Health Minister
January 12, 2016
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Earlier this month, the Ministry of Finance (MOF) unveiled a long list of social security proposals towards the FY2025 budgeting,…
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A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…
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The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…
A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…
Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…