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 Panel Members Want Clearer Standard for SaMD Efficacy in 2-Stage Approval Scheme
December 27, 2023
- Health Minister Vows to Beef Up Japan’s Innovation Ecosystem in 2024
December 27, 2023
- Health Ministry Panel Explores Vision for Generic Industry, Eyes Structural Reform in 5 Years
December 26, 2023
- Japan Officially Drops Japanese PI Requirement before Global Trial Entry
December 26, 2023
- Japan Filing within 3 Months of Global Submission Eligible for Sakigake: MHLW
December 26, 2023
- Japan Ends Supply of Takeda/Novavax’s COVID Jab, 7.14 Million Doses Discarded
December 26, 2023
- Kaigen Pharma Hit by Suspension Order for Decades of Illicit Manufacturing
December 25, 2023
- MHLW Budget Hits Record High at 33.8 Trillion Yen, Ups Funding for Drug Innovation
December 25, 2023
- (Update) Sawai Slapped with Biz Improvement Order over Rigged Quality Tests
December 25, 2023
- MHLW Announces “Innovation Box” Tax Regime: FY2024 Reform
December 25, 2023
- Japan Approves Label Expansions for Rexulti, Rituxan, and More
December 25, 2023
- Japan Grants Orphan Tags to Keytruda, Teprotumumab, and 3 More Drugs
December 25, 2023
- Ryukaikon OKs Revised Distribution Guidelines, Pharmas Urged to Explain Rationale of Solo Wholesaler Policy
December 22, 2023
- Japan Aims for 80% Unit-Price Negotiation Rate by FY2026-End: Reform Timeline
December 22, 2023
- Chuikyo OKs Outline of FY2024 Drug Pricing Reform; No Unprofitability Re-Pricing for 7%-Plus Price Gap
December 21, 2023
- Health Ministry Panel OKs Inclusion of 5-in-1 Jab in NIP from Next April
December 21, 2023
- Japan to Roll Out New LLP Coverage Rule in October; 18 Billion Yen Saving Eyed for FY2024
December 21, 2023
- Masaki Ogushi Promoted to Chief of LDP’s Health Division
December 21, 2023
- Japan to Cut Drug Prices by 0.97% on Healthcare Cost Basis in FY2024
December 20, 2023
- Gist of FY2024 Drug Pricing Reform
December 20, 2023
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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…