10/30付で米国FDA/CBERから「Tissue Notices, Proposed and Final Rules」と称し、「ヒト細胞・組織及び関連製品に関する通知・ガイダンス等を整理した」旨の連絡が発出されています。
日本で言えば、GCTP省令関連通知の整理連絡のようなものかと思います。
関係者にあっては下記URLをご参照ください。
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ActsRulesRegulations/TissueProposedFinalRules/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
なお、当該ウェブ記載の各通知・ガイダンスは以下の通りです。
日本で言えば、GCTP省令関連通知の整理連絡のようなものかと思います。
関係者にあっては下記URLをご参照ください。
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ActsRulesRegulations/TissueProposedFinalRules/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
なお、当該ウェブ記載の各通知・ガイダンスは以下の通りです。
Notices
- Federal Register Notice: Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
10/30/2015 - Federal Register Notice: Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Reopening of the Comment Period
10/30/2015 - Federal Register Notice: Human Cells, Tissues, and Cellular and Tissue-Based Products From Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry; Reopening of the Comment Period
10/30/2015 - Federal Register Notice: Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening of the Comment Period
10/30/2015 - Federal Register Notice: Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments
10/30/2015 - Federal Register Notice: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection With Treponema pallidum (Syphilis); Guidance for Industry
9/9/2015 - Federal Register Notice: Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry
2/20/2015 - Federal Register Notice: Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations; Draft Guidance
12/24/2014 - Federal Register Notice: Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance
12/23/2014 - Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products
Notice; 6/20/2014 - Guidance for Industry: BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System
3/5/2014 - Guidance for Industry and Food and Drug Administration Staff: IND App for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With DisordersAffecting the Hematopoietic System
3/5/2014 - Draft Guidance for Industry: Use of Donor Screening Tests To Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection With Treponema pallidum (Syphilis); Availability
11/5/2013 - Withdrawn - Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells
8/17/2011 - Clarifying Edits to Existing Special Controls Guidance Documents
Proposed Rules
Final Rules
- Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling
- Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation
- Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Correction
- Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement; Final Rule
- Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Final Rule
- Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Correction
- Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing
- Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing
- Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing
執筆者について
古田土 真一
経歴
GMDPコンサルタント（Pharmaceutical Quality Science Advisor） 1979年より田辺製薬(株)(現田辺三菱製薬)にて合成探索研究、プロセス・工業化研究、CMCプロジェクト開発、治験薬QA、コーポレートQAを歴任。2008年より武州製薬(株)にてQA/QCの管理監督。2009年より中外製薬(株)にて治験薬・医薬品のQA業務・品質システムを改革推進。2013年よりアステラス・アムジェン・バイオファーマ(株)にてCMC・Supply Chain・QAの長として業務構築。2015年より三井倉庫ホールディングス(株)にてヘルスケア製品の事業開発アドバイザーとして業務構築。2015年9月より (国立研究開発法人) 国立精神・神経医療研究センター／トランスレーショナル・メディカルセンター臨床研究支援部アドバイザーとして医薬品開発を、また2022年11月からジェダイトメディスン(株)の品質アドバイザーとして医薬品上市を支援中。
医薬品の開発から上市・保管・流通までを品質の側面から一貫した経験を活かし、GMDPコンサルタントとしてGood Practicesの支援依頼に対応中。
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