Designated Intractable Diseases: Draft Amendments to MHLW Notice and Diagnostic Criteria (Comment Results)
難病の患者に対する医療等に関する法律第五条第一項の規定に基づき厚生労働大臣が指定する指定難病及び同法第七条第一項第一号の規定に基づき厚生労働大臣が定める病状の程度の一部を改正する件（案）及び「指定難病に係る診断基準及び重症度分類等について」の一部改正（案）に関する御意見の募集の結果について
Published: 2026-09-28 · Source: e-Gov Public Comment · Stage: Public Comment Results Published · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · Comment deadline: 2026-10-29 23:59 JST · First detected by this dashboard: 2026-09-30
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AI summary
Generated by AI from the Japanese source metadata. It is an unofficial monitoring aid, not legal advice, and may contain errors. The area, stage, and impact labels are preliminary keyword-based triage labels. Confirm every point in the original Japanese source.
Summary
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 partial revision of the document on diagnostic criteria and severity classification for designated intractable diseases. The metadata lists a draft publication date of 2026/09/28 and a comment deadline of 2026/10/29, and the contact is the Intractable Disease Control Division of the Ministry of Health, Labour and Welfare. The amendments are described as drafts; the metadata does not state their final content or effective date.
Business Impact
If the amendments are finalized, changes to the list of designated diseases or to diagnostic criteria and severity classifications could affect eligibility for medical expense subsidies and related administrative handling. Healthcare providers, designated medical institutions, and organizations involved in intractable disease care or research may wish to assess whether they are affected.
Recommended Action
Review the official Japanese source on e-Gov, including the draft text and the published comment results, to confirm the actual content, status, and any timing of the amendments.