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
- MHLW Panel Backs Approval of Novartis’s Melanoma Drugs
February 2, 2016
- MHLW Allows Shipment of Kaketsuken’s Hep A, B Vaccines
February 2, 2016
- Chuikyo Reps Want Price-Based Penalty Added to Supplementary Opinions for FY2016 Reform Proposal, MHLW Expresses Caution
February 1, 2016
- Govt Says It’s “Not Recommending” Research-Driven Makers to Become Generic Makers, It’s One Option
February 1, 2016
- MHLW Sends Alert on Opdivo’s Fulminant Type 1 Diabetes Risk
February 1, 2016
- Suspended-but-Shipped Drugs Should Face 20% Price Cut, Chuikyo Member Says amid Kaketsuken Fuss
January 28, 2016
- MHLW in Final Stages of Study Aimed at Drafting Guidelines on Nucleic Acid Therapeutics; Final Report Due Out FY2016-End
January 28, 2016
- “Huge-Seller” Re-Pricing Created due to Drugs with Huge Financial Impact: Govt
January 27, 2016
- New Basic Guidelines for Hepatitis Measures to Promote Drug Discovery for Hep B
January 27, 2016
- Sakigake Products Added to Scope of Priority Review: MHLW Notification
January 26, 2016
- 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
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Earlier this month, the Ministry of Finance (MOF) unveiled a long list of social security proposals towards the FY2025 budgeting,…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…
The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
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…