参考文献・出典
- Regenerative Medical Products｜PMDA
- GMP/QMS/GCTP適合性調査業務｜PMDA
- GCTP適合性調査｜PMDA
- 21 CFR Part 1271 — Human Cells, Tissues, and Cellular and Tissue-Based Products｜eCFR
- Current Good Tissue Practice and Additional Requirements for Manufacturers of HCT/Ps｜FDA
- Cellular & Gene Therapy Guidances｜FDA
- Chemistry, Manufacturing, and Control Information for Human Gene Therapy IND Applications｜FDA
- Regenerative Medicine Advanced Therapy Designation｜FDA
- Advanced Therapy Medicinal Products: Overview｜EMA
- New guidelines on GMP for advanced therapies｜EMA
- Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products｜European Commission
- Pharmacovigilance for advanced therapies｜EMA
- Guideline on safety and efficacy follow-up and risk management of ATMPs｜EMA
【確実性: 高】
制度の大枠比較としては高いです。ただし、米国の361/351 HCT/P分類、EUのHospital Exemption、組合せ製品、治験段階・市販後段階の要件は製品ごとに変わるため、個別開発では専門家確認が必要です。
総PV：5,821 (+0 / 基準日: 2026-06-03)
コメントを残す