Enforcement record
指定 disclosure naming 大日本住友製薬株式会社
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
Action type
指定
Law
Pharmaceutical Affairs Act
Authority
Ministry of Health, Labour and Welfare
Action date
28 February 2017
Current page: Enforcement record
This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.
Source verification
Public-source and preservation status
- Publishing authority
- Ministry of Health, Labour and Welfare
- Official source URL
- Recorded by RegBase
- Entity match
- Not confirmed; shown under the published name
- Kiroku preservation
- Queued for preservation
- Captured: Jul 12, 2026, 04:04 PM JST
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Action summary
- Company
- 大日本住友製薬株式会社Japanese onlyOriginal: 大日本住友製薬株式会社
- Governing law
- Pharmaceutical Affairs Act薬事法
- Action type
- 指定指定
- Action date
- 28 February 2017
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
This concerns Parkinson's disease treatment using non-autologous iPS cell-derived dopamine neural precursor cells, which have a different mechanism of action from conventional treatments. Although there is no clinical experience, non-clinical efficacy evaluations have reported significant symptom improvement (more than 40% in motor symptom scores) from six months after transplantation, as well as dopamine synthesis and reuptake activity (PET imaging) at the transplantation site in the brain.
Show original Japanese text
非自己iPS細胞由来ドパミン神経前駆細胞を用いたパーキンソン病治療であり、従来の治療法とは異なる作用機序を有する。臨床使用経験はないが、非臨床有効性評価により、移植6か月後から症状の有意な改善（運動症状スコア40％以上）と脳内移植部位でドパミン合成及びドパミン再取込み活性（PET画像）が認められたとの報告がある。
Compliance context
Context neededThis is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.
Japanese regulatory disclosure under Pharmaceutical Affairs Act.
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Language
日本語版を見る (Japanese)About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.