Japan’s ruling coalition sustained a crushing blow in the Lower House election last month, only managing to win 215 seats,…
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REGULATORY
- PAFSC 2nd Committee to Review 5 Products Including Novartis’s COPD Drug on Sept. 6
August 24, 2012
- Domestic Pharmaceutical Production Up 3.1 %, to Record high 6,987.4 Bil. Yen in 2011
August 24, 2012
- Two Healthcare Provider Reps at CSIMC Criticize Marketing of a Single Drug under Different Brand Names as “Undesirable”
August 24, 2012
- CSIMC Expert Subcommittee Favors Single Index for Efficacy Assessment of Medical Technology
August 24, 2012
- Drug Pricing Subcommittee Presents Negative Views on Reference Pricing System; “Concerns over Patient Copayment Increases”
August 24, 2012
- MHLW to Recommend Use of ReQuip CR Tablets
August 23, 2012
- CSIMC Approves Listing for 6 APIs/10 Products; Peak Sales Projected at 45.6 Billion Yen for Tenelia
August 23, 2012
- Nonpartisan League of Diet Members Aims to Submit Bill during Current Diet Session to Promote Measures against Strokes
August 23, 2012
- Introduction of RMPs Will Enable Clearer Strategies for Post-Marketing Safety: Ms Tawaragi of PFSB
August 23, 2012
- MHLW Budget Request to Focus on Life Innovation: Minister Komiyama
August 22, 2012
- PMDA’s Regulatory Consultation Service Off to Good Start, but More Effort Needed to Promote Face-to-Face Advisory Meetings: Dr Isobe
August 22, 2012
- Healthcare to Receive Priority in FY2013 Draft Budget Request Guidelines
August 21, 2012
- PAFSC’s 1st Committee to Review 7 Products Including Bayer Yakuhin’s AMD Drug on Aug. 31
August 20, 2012
- Subcommittee on Refractory Diseases Prepares to Improve Medical Expenditure Subsidies: Interim Report
August 20, 2012
- PMDA Meets Targets for FY2011, but Measures Needed to Reduce Applicants’ Processing Time: MHLW’s Evaluation Council
August 20, 2012
- MHLW Designates 4 Products Including Thyroid Cancer Agent as Orphan Drugs
August 20, 2012
- US Regulation Could Delay Introduction of PBRER as ICH Standard
August 17, 2012
- 215 Preliminary Interviews Given for Regulatory Strategy Consultation in 1st Year: PMDA
August 17, 2012
- MHLW Approves Allegra Generics of 3 Companies for Listing in December
August 16, 2012
- MHLW Announces that Manufacturer’s Suggested Retail Prices of DPT-IPV Start at 6,500 Yen
August 15, 2012
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For over two decades, Morunda has been at the forefront of interviewing and understanding leaders within Japan’s dynamic healthcare industry, particularly in pharmaceuticals and medical devices. What sets apart successful country managers in this competitive arena isn’t just their professional…
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…