Japan Healthcare & Pharmaceutical Regulation Updates
Official Japanese developments on pharmaceuticals, medical devices, drug safety information, and healthcare administration, monitored daily from government, regulator, Diet, and self-regulatory sources and labelled in English for triage. Area labels are assigned by keyword rules for triage, so this page may miss relevant items or include marginal ones.
275 updates tracked · 183 with AI summaries · 7 open public comments · last checked 2026-10-06
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Open public comments
Consultations still accepting comments, soonest deadline first. Confirm the deadline and submission method in the official source.
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Public Comment on Proposed Amendments to MHLW Designations of Class 1 and Class 2 OTC Drugs under the PMD Act
Comments due: 2026-10-09 00:00 JST
This is a public comment (out for public comment) on draft amendments to the Minister of Health, Labour and Welfare's designations of certain Class 1 and Class 2 non-prescription drugs under Article 36-7 of Japan's Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices (PMD Act), and to… (AI summary)
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Public Comment: Draft Designation of Pharmaceuticals by the MHLW Minister under Article 68-2(1) of the PMD Act
Comments due: 2026-10-10 00:00 JST
This is a public comment invitation on a draft designating pharmaceuticals to be specified by the Minister of Health, Labour and Welfare under Article 68-2, paragraph 1 of Japan's Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act). According to the… (AI summary)
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Public Comment on Draft Notice Amending Specialist Qualification Certification for Intractable Disease and Child...
Comments due: 2026-10-19 00:00 JST
This is a public comment invitation from Japan's Ministry of Health, Labour and Welfare regarding a draft notice that would partly amend provisions on specialist qualifications certified by designated certification bodies. The provisions relate to the Enforcement Regulations of the Act on Medical Care for Patients… (AI summary)
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Public Comment on Proposed Revisions to Japanese Industrial Standards for Medical Devices
Comments due: 2026-10-25 23:59 JST
The Ministry of Health, Labour and Welfare (Pharmaceutical Safety and Environmental Health Bureau, Medical Device Evaluation Division) has opened a public comment period on proposed revisions to Japanese Industrial Standards (JIS) relating to medical devices. According to the metadata, the proposal was published on… (AI summary)
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Public comment: draft amendment to MHLW list of designated OTC-guidance (yo-shido) drugs
Comments due: 2026-10-31 00:00 JST
This is a public comment solicitation on a draft (proposed) notice that would partly amend the list of 'drugs requiring guidance' (yo-shido iyakuhin) designated by the Minister of Health, Labour and Welfare under Article 4, paragraph 5, item 3 of the Pharmaceuticals and Medical Devices Act. The draft was announced on… (AI summary)
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Draft Japanese Pharmacopoeia Crude Drug Standards 2026 – Public Comment
Comments due: 2026-11-05 00:00 JST
The Ministry of Health, Labour and Welfare is seeking public comments on a draft of the 'Japanese Pharmacopoeia Crude Drug Standards 2026' (Nihon Yakkyokuho-gai Seiyaku Kikaku 2026). The draft was announced on 2026-10-06, and the comment period is listed as closing on 2026-11-05 at 00:00. The inquiry contact is the… (AI summary)
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Public Comment: Draft Revision of Japanese Industrial Standards for Medical Devices
Comments due: 2026-11-28 23:59 JST
The Japanese government has opened a public comment period on a draft revision of Japanese Industrial Standards (JIS) relating to medical devices. The draft was announced on 2026-09-29, and comments are accepted until 2026-11-28 23:59. The listed contact is the Medical Device Evaluation Division, Pharmaceutical… (AI summary)
Latest updates
Newest official publications first.
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Draft Japanese Pharmacopoeia Crude Drug Standards 2026 – Public Comment
The Ministry of Health, Labour and Welfare is seeking public comments on a draft of the 'Japanese Pharmacopoeia Crude Drug Standards 2026' (Nihon Yakkyokuho-gai Seiyaku Kikaku 2026). The draft was announced on 2026-10-06, and the comment period is listed as closing on 2026-11-05 at 00:00. The inquiry contact is the… (AI summary)
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PMDA Class I recall notice: Fresh Frozen Plasma-LR "Nissekis" 480
The Pharmaceuticals and Medical Devices Agency (PMDA) safety information page lists a Class I recall entry for the product "Fresh Frozen Plasma-LR 'Nisseki' 480" (Japanese Red Cross), published 2026-10-05. The provided metadata contains only the title and a generic PMDA safety-update description, so the reason for… (AI summary)
- PMDA Safety Update: Pharmaceutical or medical device safety information published (2026-10-05)
- PMDA Safety Update: Pharmaceutical or medical device safety information published (2026-10-05)
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PMDA posts MHLW notice on revising package insert precautions for drugs (Oct 2, 2026)
The PMDA Safety Updates page announced that it has posted a notice instructing revisions to the 'precautions for use' (package insert precautions) of pharmaceutical products, issued by the Ministry of Health, Labour and Welfare and dated October 2, 2026. This is a government announcement; the metadata does not… (AI summary)
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PMDA posts notice: 86th Report of Medical Accident Information Collection Project published
The PMDA Safety Updates page lists a new entry stating that the 86th report of the Medical Accident Information Collection Project (as translated from the Japanese title) has been published. The item is a government announcement dated 2026-10-02; the provided metadata does not include the report's contents or findings. (AI summary)
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Public comment: draft amendment to MHLW list of designated OTC-guidance (yo-shido) drugs
This is a public comment solicitation on a draft (proposed) notice that would partly amend the list of 'drugs requiring guidance' (yo-shido iyakuhin) designated by the Minister of Health, Labour and Welfare under Article 4, paragraph 5, item 3 of the Pharmaceuticals and Medical Devices Act. The draft was announced on… (AI summary)
- Digital Agency Update: Regulatory announcement related to Healthcare / Pharmaceuticals (2026-09-30)
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Public Comment: Draft Revision of Japanese Industrial Standards for Medical Devices
The Japanese government has opened a public comment period on a draft revision of Japanese Industrial Standards (JIS) relating to medical devices. The draft was announced on 2026-09-29, and comments are accepted until 2026-11-28 23:59. The listed contact is the Medical Device Evaluation Division, Pharmaceutical… (AI summary)
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PMDA posts MHLW notice directing revision of precautions for drugs (dated 29 Sep 2026)
PMDA's safety updates page lists a post stating that a notice instructing revisions to the 'Precautions' (package-insert cautionary information) for pharmaceuticals, issued by the Ministry of Health, Labour and Welfare and dated 29 September 2026, has been published. The available metadata does not identify which… (AI summary)
- PMDA Safety Update: Pharmaceutical or medical device safety information published (2026-09-29)
- MHLW Update: Regulatory announcement related to Healthcare / Pharmaceuticals (2026-09-29)
- PMDA Safety Update: Pharmaceutical or medical device safety information published (2026-09-29)
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Designated Intractable Diseases: Draft Amendments to MHLW Notice and Diagnostic Criteria (Comment Results)
This e-Gov item concerns the results of a public comment procedure on draft partial amendments to the Minister of Health, Labour and Welfare's designation of 'designated intractable diseases' and the prescribed severity levels under the Act on Medical Care for Patients with Intractable Diseases, as well as a draft… (AI summary)
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PMDA Adds May 2026 Data on Suspected Malfunction Case Reports for Combination Products
The Pharmaceuticals and Medical Devices Agency (PMDA) has announced an update adding May 2026 information to its dataset of case reports of suspected malfunctions involving combination products. This appears to be a routine safety-information update published on the PMDA safety services page. The official Japanese… (AI summary)
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PMDA Adds May 2026 Data to Suspected Medical Device Malfunction Case Reports
The Pharmaceuticals and Medical Devices Agency (PMDA) announced that it has added information for May 2026 to its collection of case reports concerning suspected malfunctions of medical devices. This is a routine safety information update published on the PMDA safety services page. The details of the added case… (AI summary)
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PMDA Adds May 2026 Data to Suspected Adverse Case Reports for Regenerative Medical Products
The Pharmaceuticals and Medical Devices Agency (PMDA) announced that it has added information for May 2026 to its collection of suspected adverse (defect-related) case reports concerning regenerative medicine and similar products. This is a routine safety update posted under the PMDA safety operations section. The… (AI summary)
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Public Comment on Draft Notice Amending Specialist Qualification Certification for Intractable Disease and Child...
This is a public comment invitation from Japan's Ministry of Health, Labour and Welfare regarding a draft notice that would partly amend provisions on specialist qualifications certified by designated certification bodies. The provisions relate to the Enforcement Regulations of the Act on Medical Care for Patients… (AI summary)
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PMDA Adds May 2026 Data to Suspected Adverse Drug Reaction Case Reports
The Pharmaceuticals and Medical Devices Agency (PMDA) announced that it has added information for May 2026 to its 'Information on Suspected Adverse Drug Reaction Case Reports.' This is a routine safety-information update published on the PMDA website. No specific drug, product, or regulatory action is described in… (AI summary)
- Digital Agency Update: Regulatory announcement related to Healthcare / Pharmaceuticals (2026-09-18)
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PMDA Posts Package Insert Revisions for Drugs Based on Revision Consultations
The Pharmaceuticals and Medical Devices Agency (PMDA) has published an update indicating package insert (product labeling) revisions for pharmaceuticals based on package insert revision consultations. This item appears in the PMDA's safety measures new information listing. Specific drugs and the nature of the… (AI summary)
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PMDA Publishes Package Insert Revisions for Pharmaceuticals Based on Consultation
The Pharmaceuticals and Medical Devices Agency (PMDA) posted a safety update indicating that package insert (product labeling) revisions for pharmaceuticals, based on package-insert revision consultations, have been published. This is a government safety announcement; specific products or revision details are not… (AI summary)
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PMDA Publishes Package Insert Revisions for Drugs Based on Revision Consultations
The Pharmaceuticals and Medical Devices Agency (PMDA) has posted new information in its safety updates announcing package insert (labeling) revisions for pharmaceuticals arising from package insert revision consultations. This is a government safety announcement; specific products and details are not provided in the… (AI summary)
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PMDA Publishes Package Insert Revisions for Drugs Based on Revision Consultations
The Pharmaceuticals and Medical Devices Agency (PMDA) has posted a safety-related announcement stating that package insert (labeling) revisions for pharmaceuticals, based on package insert revision consultations, have been published. This is a government safety-information update; the specific drugs and details of… (AI summary)
- MHLW Update: Regulatory announcement related to Healthcare / Pharmaceuticals (2026-09-14)
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Cabinet Order on Related Order Adjustments and Transitional Measures Following Partial Enforcement of the Act...
This item concerns a Cabinet Order (Reiwa 8 Cabinet Order No. 274) addressing adjustments to related Cabinet Orders and transitional measures accompanying the partial enforcement of the Act amending the Medical Care Act and related acts. According to the metadata, it affects the Cabinet Order on personnel retirement… (AI summary)
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Cabinet Order on Related Cabinet Orders and Transitional Measures for Medical Care Act Amendments
The e-Gov update list shows a Cabinet Order (Reiwa 8 Cabinet Order No. 274), promulgated on 2026-09-11, that amends the Cabinet Order designating public corporations under Article 7, Paragraph 1 of the Act on the Authority of the Minister of Justice in Litigation Concerning the State's Interests (Showa 37 Cabinet… (AI summary)
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Cabinet Order on Related Orders and Transitional Measures for Medical Care Act Amendment (MHLW Organization Order)
The e-Gov update list shows a Cabinet Order (Reiwa 8 Cabinet Order No. 274), titled as providing for the adjustment of related cabinet orders and transitional measures accompanying the partial enforcement of an Act partially amending the Medical Care Act and others. According to the metadata, it amends the Order for… (AI summary)
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Cabinet Order on Related Orders and Transitional Measures for Partial Enforcement of Medical Care Act Amendments
The e-Gov law update list shows a Cabinet Order (Reiwa 8 Cabinet Order No. 274) that amends related orders, including the Enforcement Order of the National Public Service Retirement Allowance Act (Showa 28 Cabinet Order No. 215), in connection with the partial enforcement of an Act amending the Medical Care Act and… (AI summary)
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Cabinet Order amending National Public Service Mutual Aid Association Act Enforcement Order (Medical Care Act reform)
This e-Gov update-list entry shows a Cabinet Order, titled as concerning the preparation of related cabinet orders and transitional measures accompanying partial enforcement of an Act partially amending the Medical Care Act and others. It lists the National Public Service Mutual Aid Association Act Enforcement Order… (AI summary)
Most frequent sources in this area
- e-Gov Law Search — Updated Laws (139)
- Pharmaceuticals and Medical Devices Agency (PMDA) — Safety Updates (93)
- e-Gov Public Comment (28)
- Ministry of Health, Labour and Welfare (MHLW) (11)
- Digital Agency (3)
- House of Representatives — Diet Bills (1)