Japan’s health ministry approved a slew of new medicines on September 25 including multiple “first of its kind” products, among them being GlaxoSmithKline’s respiratory syncytial virus (RSV) vaccine Arexvy as well as Eisai’s Alzheimer’s therapy Leqembi (lecanemab).Arexvy became the first…
HOME > MHLW Panel on Pharmaceutical Regulations
MHLW Panel on Pharmaceutical Regulations
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Japan to Basically Drop Japanese PI Requirement before Global Clinical Trials
September 14, 2023
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Approve 16 Pediatric Cancer Meds as Exceptional Step Beyond Law, Oncologist Urges
August 8, 2023
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Pharma Regulation Panel to Discuss Need for PI Japanese Data on Aug. 7
August 1, 2023
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MHLW Pharma Bureau Chief Eager to Do Everything on Regulation Panel’s Agenda
July 25, 2023
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MHLW Presents Plan to Expand Orphan Drug Designation by Clarifying Requirements
July 11, 2023
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Boost PMDA Manpower to Respond to Proposed Orphan Revamp: Panelists
July 11, 2023
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MHLW Proposes Simultaneous Preparation of Drug Development Plans for Adults and Children
July 11, 2023
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MHLW Pharma Regulation Panel Kicks Off, Agrees to Discuss Incentives to Develop Pediatric Drugs
July 11, 2023
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MHLW to Launch Pharma Affairs Study Group July 10, Drug Loss Up for Debate
July 4, 2023
“Time is the scarcest resource, and unless it is managed, nothing else can be managed.” - Peter DruckerSearching for the right candidate takes time… but how much time?The last thing you want is to waste time searching for the wrong…
In the run-up to FY2024 budget requests this summer, there were growing hopes in the pharmaceutical industry that the government's de-facto cap on increases in social security spending would finally be lifted. That did not happen, despite strong calls from…
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…