Japan’s general trading houses are steadily becoming a force to be reckoned with in the pharmaceutical industry — and not…
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MHLW Panel on Pharmaceutical Regulations
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Regulation Panel’s Final Report Specifies Exemptions for All-Case PMS
April 25, 2024
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Japan Set to Push Central IRBs for Clinical Trials, Avoid Customary All-Case PMS
March 22, 2024
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Japan to Allow Submissions without Japanese Data If All Requirements Met
February 9, 2024
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Pharma Regulation Panel to Explore Potential Criteria for All-Case PMS Requirement
January 15, 2024
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Panel Discusses Potential Waiver of Japanese Trials for Ultra-Orphan Medicines
December 14, 2023
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MHLW Plans Joint Surprise Onsite Inspections by PMDA and Prefectural Govts
November 16, 2023
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MHLW Panel Pins Hope on PMDA’s Overseas Offices to Foster Global Appeal of Japan Market
November 16, 2023
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MHLW Regulatory Panel OKs New Procedures for Post-Approval Manufacturing Changes
October 16, 2023
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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
A public-private council report outlining industry views on Japan’s drug pricing systems drew little discussion at a meeting of the…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
In the complex tapestry of leadership, awareness isn’t just a desirable trait; it’s the bedrock upon which success is built. It’s the lens through which leaders perceive, interpret, and navigate the ever-shifting landscape of their organizations and industries. Without it,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…