The traditional HR Business Partner (HRBP) model, once the gold standard for HR delivery, is undergoing a significant transformation. Many organizations, particularly in industries like pharmaceuticals, are moving towards a more agile resource model, aiming to streamline HR operations and…
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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
For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…
The Ministry of Health, Labor and Welfare (MHLW) posted the final report compiled by its pharmaceutical regulation panel on its website on April 24, providing cases of drugs that could be exempted from all-case post marketing surveillance (PMS).The MHLW plans…