PMD Act (Japan)

Japan METI and MHLW Establish Taskforce to Secure Pharmaceuticals, Medical Devices and Medical Supplies Affected by Middle East Situation

Japan has established a joint ministerial taskforce to address supply chain vulnerabilities for pharmaceuticals and medical devices linked to geopolitical instability in the Middle East. Businesses should anticipate increased government scrutiny of supply resilience and potential future measures to ensure the stable availability of critical medical supplies.

1 Apr 2026, 19:46meti.go.jpJapan

Japan MHLW Ordinance No. 30 of 2026 Amends PMD Act Enforcement Regulations on Poison and Advertising-Restricted Medicines

Japan's MHLW promulgated Ordinance No. 30 of 2026 on March 23, 2026, to immediately designate newly approved medicines as poisons or advertising-restricted drugs. This eliminates regulatory gaps between approval and classification, requiring firms to ensure labeling and marketing compliance are finalized prior to market entry.

26 Mar 2026, 19:12public-comment.e-gov.go.jpJapan

Japan MHLW Amends Designation of Biological and Specified Biological Products (Notification No. 106 of 2026)

Japan’s MHLW updated the list of designated biological and specified biological products under the PMD Act, effective March 2026. Manufacturers and importers must verify product classifications to ensure compliance with the heightened safety and quality control requirements mandated for biological medicines.

26 Mar 2026, 19:11mhlw.go.jpJapan

Japan MHLW Issues Notice No. 105 (Reiwa 8) Amending Designated Medicines Under PMD Act Article 49(1)

Japan's MHLW has updated the list of designated prescription medicines under the PMD Act, effective March 23, 2026, to ensure immediate regulatory control over newly approved drugs. Marketing authorization holders must verify the status of new products to ensure immediate compliance with dispensing and labeling requirements for designated medicines.

26 Mar 2026, 19:11public-comment.e-gov.go.jpJapan

Japan Authorities Consult On Amendments To Hazard Information Reporting Ordinance And Guidance Under CSCL

Japan is modernizing CSCL hazard reporting by transitioning to electronic submissions and refining data requirements for monitoring and Class II substances, effective May 2026. Companies must update internal reporting workflows for digital compliance and assess expanded data obligations for Class II substances to ensure alignment with the revised ordinance.

19 Mar 2026, 19:34public-comment.e-gov.go.jpJapan

Japan MHLW Consults On Draft Guideline For Quality Assurance Of Human Cell-Derived Extracellular Vesicle (EV) Medicines

Japan's MHLW has proposed a new quality assurance guideline for human cell-derived natural extracellular vesicle (EV) medicines, with consultation open until April 16, 2026. This framework establishes critical manufacturing and characterization standards for EV-based therapies, signaling a formal path for market authorization and alignment with international quality expectations.

19 Mar 2026, 19:29public-comment.e-gov.go.jpJapan

Japan Proposes Designating Four Substances as Shitei Yakubutsu Under PMD Act

Japan is designating four new psychoactive substances as "Shitei Yakubutsu" under the PMD Act, effective March 14, 2026. This action imposes a strict ban on manufacture, import, and sale, necessitating immediate inventory and supply chain reviews to mitigate compliance risks.

12 Mar 2026, 14:50eping.wto.orgJapan

Japan 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 (PMD Act) as of March 2026. Businesses must audit product portfolios against the updated substance list to mitigate legal risks associated with the distribution of newly controlled or restricted substances.

12 Mar 2026, 13:44kanpo.go.jpJapan

Japan MHLW Seeks Comments on OTC Switch for Tocopherol Nicotinate

Japan’s MHLW is consulting on the reclassification of tocopherol nicotinate from prescription to over-the-counter (OTC) status through April 2026. This potential "switch OTC" offers market expansion opportunities but necessitates proactive assessment of consumer safety profiles, labeling requirements, and risk-mitigation strategies.

11 Mar 2026, 17:18public-comment.e-gov.go.jpJapan

Japan 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.

10 Mar 2026, 11:32kanpo.go.jpJapan

Japan: MAFF Ordinance Adds Amlodipine and Fluralaner to Veterinary Medicinal Product Controls

Japan has added amlodipine and fluralaner to its controlled veterinary medicinal products list, effective February 26, 2026. Manufacturers must ensure immediate compliance with revised classification and handling requirements for these active ingredients in livestock and pet medications.

5 Mar 2026, 12:52kanpo.go.jpJapan

Japan 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 move ensures immediate regulatory oversight for newly authorized drugs, requiring manufacturers to align distribution and marketing strategies with prescription-only requirements.

24 Feb 2026, 19:13public-comment.e-gov.go.jpJapan

Japan MHLW Specifies Quantities Under PMD Act Enforcement Regulations (Article 159-18-6(1))

Japan's MHLW has finalized specific quantity thresholds under the PMD Act Enforcement Regulations, effective February 13, 2026. Regulated entities must verify these numerical limits to ensure compliance with updated safety, quality, and reporting obligations for pharmaceuticals and medical devices.

16 Feb 2026, 16:50kanpo.go.jpJapan

Japan MEXT Publishes Consultation Results and Adopts Amendments to Human ES/iPS Cell Research Guidelines

Japan has finalized amendments to four bioethics guidelines governing human ES and iPS cell research, effective February 2026. Research institutions must ensure internal ethics protocols and reporting procedures align with updated oversight requirements for stem cell establishment, distribution, and use.

15 Feb 2026, 19:19public-comment.e-gov.go.jpJapan

Japan MHLW Consults On Amendments To Guidance And Q&A On Standards For Biological Raw Materials

Japan’s MHLW is consulting on updated operational guidance for biological raw materials used in pharmaceuticals and medical devices (February 2026). Manufacturers must prepare for revised donor screening, viral inactivation, and traceability requirements to ensure continued market access for bio-derived products.

13 Feb 2026, 07:58public-comment.e-gov.go.jpJapan

Japan MHLW Amends List of Pharmaceuticals Requiring Testing Under PMD Act

Japan’s MHLW has updated the list of pharmaceuticals and medical products subject to mandatory testing under the PMD Act as of February 2026. Impacted manufacturers and importers must review the revised designations to ensure compliance with testing protocols and avoid delays in market distribution.

12 Feb 2026, 15:58kanpo.go.jpJapan

Japan Amends Standards for Biological Preparations

Japan published amendments to the Standards for Biological Preparations on February 10, 2026, updating technical specifications for biological medicinal products. Manufacturers must review revised monographs and test methods to ensure continued compliance with Japanese quality and safety standards.

12 Feb 2026, 15:38kanpo.go.jpJapan

Japan MHLW Amends Standards for Artificial Blood Vessels and Medical Adhesives and Abolishes Contact Lens Standards

Japan has updated technical standards for artificial blood vessels and medical adhesives while abolishing specific standards for vision-correcting contact lenses (February 2026). Manufacturers must verify product specifications and testing protocols against the revised requirements to maintain market access and ensure compliance with the PMD Act.

6 Feb 2026, 08:51kanpo.go.jpJapan

Japan Proposes Amendments To Standards For Biological Raw Materials (G/TBT/N/JPN/898)

Japan is proposing to ease restrictions on bovine-derived raw materials used in pharmaceuticals, cosmetics, and medical devices by excluding certain cattle parts from prohibited lists. This alignment with international animal health standards simplifies sourcing for biological raw materials while maintaining strict safety controls under the PMD Act.

27 Jan 2026, 10:43docs.wto.orgJapan

Japan MAFF Amends Regulations on the Control of Veterinary Medicinal Products

Japan’s Ministry of Agriculture, Forestry and Fisheries has amended the regulations governing the licensing, manufacturing, and safety of veterinary medicinal products. Businesses must evaluate updated marketing authorization and change-control requirements to maintain compliance and avoid disruptions in the Japanese animal health market.

23 Jan 2026, 13:40kanpo.go.jpJapan