PMD Act (Japan)
Japan's Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices — the primary regulatory framework for pharmaceuticals, medical devices, cosmetics, and regenerative medicine.
Foresight tracks PMD Act (Japan) developments and surfaces the alerts most likely to matter before they turn into missed deadlines, recalls, or escalation work.
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Last updated
1 April 2026, 19:46
Latest PMD Act (Japan) alerts
The most recent regulatory and guidance signals tracked by Foresight
Japan METI and MHLW Establish Taskforce to Secure Pharmaceuticals, Medical Devices and Medical Supplies Affected by Middle East Situation
Japan has launched a joint ministerial taskforce to mitigate supply chain risks for pharmaceuticals and medical devices stemming from geopolitical instability in the Middle East. Companies should prepare for increased government oversight of supply resilience and potential future mandates to ensure the continuity of essential medical supplies.
JapanJapan MHLW Ordinance No. 30 of 2026 Amends PMD Act Enforcement Regulations on Poison and Advertising-Restricted Medicines
Japan has amended the PMD Act Enforcement Regulations to enable the immediate designation of newly approved medicines as poisons or advertising-restricted drugs. This eliminates regulatory gaps between approval and classification, requiring manufacturers to finalize labeling and marketing compliance strategies prior to market entry.
JapanJapan MHLW Amends Designation of Biological and Specified Biological Products (Notification No. 106 of 2026)
Japan updated the list of designated biological and specified biological products under the PMD Act in March 2026. Manufacturers must verify product classifications to ensure compliance with the stringent safety and quality control requirements mandated for these high-risk categories.
JapanJapan MHLW Issues Notice No. 105 (Reiwa 8) Amending Designated Medicines Under PMD Act Article 49(1)
Japan's Ministry of Health, Labour and Welfare has updated the list of designated prescription medicines under the PMD Act, effective March 23, 2026. Marketing authorization holders must immediately verify the classification of new products to ensure compliance with mandatory dispensing and labeling requirements.
JapanJapan Authorities Consult On Amendments To Hazard Information Reporting Ordinance And Guidance Under CSCL
Japan is transitioning to electronic hazard reporting and expanding data requirements for Class II substances under the Chemical Substances Control Law, effective May 2026. Companies should digitize reporting workflows and prepare for broader hazard data obligations to ensure compliance with updated monitoring and Class II substance rules.
JapanJapan MHLW Consults On Draft Guideline For Quality Assurance Of Human Cell-Derived Extracellular Vesicle (EV) Medicines
Japan has introduced draft quality assurance guidelines for human cell-derived extracellular vesicle medicines to standardize manufacturing and characterization requirements. This proposal creates a formal regulatory pathway for EV-based therapies, signaling a shift toward harmonized international standards for advanced medicinal products.
JapanJapan Proposes Designating Four Substances as Shitei Yakubutsu Under PMD Act
Japan is designating four new psychoactive substances as Shitei Yakubutsu under the PMD Act with enforcement beginning March 2026. This action prohibits the manufacture, import, and sale of these substances, necessitating immediate inventory reviews to mitigate compliance and market access risks.
JapanJapan MHLW Partially Amends Ordinance on Designated Drugs and Medical Uses Under PMD Act
Japan has expanded the list of designated drugs and restricted medical uses under the Pharmaceuticals and Medical Devices Act as of March 2026. Companies must immediately audit product portfolios against the updated substance list to ensure compliance with new distribution and handling restrictions.
JapanJapan MHLW Seeks Comments on OTC Switch for Tocopherol Nicotinate
Japan is consulting on the reclassification of tocopherol nicotinate from prescription to over-the-counter status through April 2026. This potential switch offers market expansion opportunities while requiring proactive assessment of consumer safety profiles and labeling requirements.
JapanJapan MHLW Amends List of Specified Pharmaceuticals Under PMD Act
Japan’s MHLW updated the list of designated pharmaceuticals under the PMD Act on March 6, 2026. Manufacturers and importers must immediately verify product classifications to ensure continued compliance with marketing and distribution obligations.
JapanJapan: MAFF Ordinance Adds Amlodipine and Fluralaner to Veterinary Medicinal Product Controls
Japan has expanded its controlled veterinary medicinal products list to include amlodipine and fluralaner, effective February 2026. Manufacturers must immediately update compliance and handling protocols for these active ingredients in livestock and pet medications.
JapanJapan MHLW Amends Designation of Prescription Pharmaceuticals Under PMD Act Article 49(1) (Notice No. 38 of 2026)
Japan's MHLW has designated new pharmaceuticals as prescription-only medicines under the PMD Act, effective February 19, 2026. This action mandates immediate alignment of distribution and marketing strategies with prescription-only requirements to ensure compliance upon market entry.
JapanJapan MHLW Specifies Quantities Under PMD Act Enforcement Regulations (Article 159-18-6(1))
Japan has finalized specific quantity thresholds under the PMD Act Enforcement Regulations, effective February 13, 2026. Manufacturers must verify these numerical limits to maintain compliance with safety and quality reporting obligations for pharmaceuticals and medical devices.
JapanJapan MEXT Publishes Consultation Results and Adopts Amendments to Human ES/iPS Cell Research Guidelines
Japan has finalized amendments to four bioethics guidelines governing human embryonic and induced pluripotent stem cell research, effective February 2026. Research institutions must update internal ethics protocols and reporting procedures to comply with revised oversight requirements for stem cell establishment and distribution.
JapanJapan MHLW Consults On Amendments To Guidance And Q&A On Standards For Biological Raw Materials
Japan is consulting on revised operational guidance for biological raw materials used in pharmaceuticals and medical devices through February 2026. Companies should evaluate proposed changes to donor screening and viral inactivation protocols to ensure supply chain compliance and continued market access for bio-derived products.
JapanJapan MHLW Amends List of Pharmaceuticals Requiring Testing Under PMD Act
Japan has updated the list of pharmaceuticals and medical devices subject to mandatory testing under the PMD Act as of February 2026. Companies must audit their product portfolios against these revised designations to prevent supply chain disruptions and ensure adherence to mandatory safety and quality standards.
JapanJapan Amends Standards for Biological Preparations
Japan updated its Standards for Biological Preparations on February 10, 2026, introducing revised technical specifications and quality test methods for biological medicinal products. Companies must evaluate their manufacturing and testing protocols against these updated requirements to ensure continued compliance and product safety in the Japanese market.
JapanJapan MHLW Amends Standards for Artificial Blood Vessels and Medical Adhesives and Abolishes Contact Lens Standards
Japan has revised technical and safety standards for artificial blood vessels and medical adhesives while streamlining requirements for vision-correcting contact lenses. Manufacturers must reassess product compliance and testing protocols to ensure continued market access under the updated medical device regulatory framework.
JapanJapan Proposes Amendments To Standards For Biological Raw Materials (G/TBT/N/JPN/898)
Japan is proposing to ease restrictions on specific bovine-derived raw materials for pharmaceuticals, cosmetics, and medical devices by aligning with international animal health standards. This regulatory shift will expand sourcing flexibility for biological ingredients while requiring manufacturers to update their supply chain risk assessments and compliance records.
JapanJapan MAFF Amends Regulations on the Control of Veterinary Medicinal Products
Japan has updated its regulatory framework for veterinary medicinal products, refining requirements for marketing authorizations, manufacturing licenses, and change-control procedures. Businesses must audit existing compliance protocols for animal health products to ensure alignment with revised standards for quality control, safety reporting, and residue limits.
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These are just a few of the most recent PMD Act (Japan) alerts. Foresight tracks every jurisdiction, every day — and surfaces only what affects your portfolio, with full citations and evidence.
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