日本细胞与基因治疗指导原则
2013-05-25 22:00:01   来源：   

Japanese Guidelines on Cellular and Gene Therapy Products
Guidelines on Gene Therapy Products
• Amendments of Guideline for Gene Therapy Clinical Research  [in Japanese]
(Notification of Research Promotion Bureau, the Ministry of Education, Culture, Sports, Science and Technology (MEXT) and Health Sciences Division, Minister's Secretariat, the Ministry of Health, Labour and Welfare (MHLW); 16 Monkashin No.931 & Ka-hatsu No.1228003; 28 Dec. 2004)
• Guideline for Gene Therapy Clinical Research [in Japanese]
(Ministerial Notification of MEXT and MHLW; 2004 No.2; 28 Dec. 2004)
• Processes for Evaluation of Gene Therapy Clinical Research Based on "Guideline for Gene Therapy Clinical Research" [in Japanese]
(Report for the Working Group of the Subcommittee, the Council for Science and Technology, the Health Science Council (HSC), MHLW; 18 Jan. 2006)
• Related to Guideline for Gene Therapy Clinical Research [in Japanese]
(Notification of Research Promotion Bureau, MEXT and Health Sciences Division, Minister's Secretariat, MHLW; 13 Monkashin No.1144 & Ka-hatsu No.0327001; 27 Mar. 2002)
• Guideline for Assuring the Quality and Safety of the Gene Therapy Products  [in Japanese]
(Notification of Pharmaceutical Affairs Bureau, the Ministry of Health and Welfare; Yaku-hatsu No.1062; 15 Nov. 1995)
• Amendments of Guideline for Assuring the Quality and Safety of the Gene Therapy Products  [in Japanese]
(Notification of Pharmaceutical and Medical Safety Bureau, MHLW; Iyaku-hatsu No.0329004; 29 Mar. 2002)
• Partial Amendments of Guideline for Assuring the Quality and Safety of the Gene Therapy Products [in Japanese]
(Notification of Pharmaceutical and Food Safety Bureau, MHLW; Yakushoku-hatsu No.1228004; 28 Dec. 2004)
• Regulations Related to "Law Concerning the Conservation and Sustainable Use of Biological Diversity through Regulation on the Use of Living Modified Organisms" (Cartagena Law)
To Web Page of Japan Biosafety Clearing House, Ministry of the Environment
• Procedures for Approval of Type 1 Use Regulation Based on Law Concerning the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms in Gene Therapy Clinical Research
(Notification of Health Sciences Division, Minister's Secretariat, MHLW; Ka-hatsu No.0219001; 19 Feb. 2004)
Notification   Attachment (MS-Word File) Appendix [all in Japanese]
Guidelines on Cellular Therapy Products
• Quality and Safety Assurance of Cell/Tissue Pharmaceuticals and Cell/Tissue-derived Medical Devices [in Japanese]
(Notification of Pharmaceutical and Medical Safety Bureau, the Ministry of Health and Welfare; Iyaku-hatsu No.906; 30 Jul. 1999)
• Partial Amendments Related to Quality and Safety Assurance of Cell/Tissue Pharmaceuticals and Cell/Tissue-derived Medical Devices [in Japanese]
(Notification of Pharmaceutical and Food Safety Bureau, MHLW; Yakushoku-hatsu No.0518001; 18 May. 2009)
• Quality and Safety Assurance of Pharmaceuticals Manufactured Using Human or Animal-derived Components as Raw Materials [in Japanese]
(Notification of Pharmaceutical and Medical Safety Bureau, the Ministry of Health and Welfare; Iyaku-hatsu No.1314; 26 Dec, 2000)
Attachment 1: Basic Concepts for the Handling and Use of Drugs and Devices Utilizing Cells or Tissues
Attachment 2: Guidelines for Assurance of Quality and Safety of Drugs and Devices Processed from Cells and Tissues of Human Origin Related to Quality and Safety Assurance of Pharmaceuticals and Medical Devices Based on Human Autologous Cells or Tissues
[Guideline for Quality and Safety Assurance of Pharmaceuticals and Medical Devices Based on Human Autologous Cells or Tissue]  [in Japanese]
(Notification of Pharmaceutical and Food Safety Bureau, MHLW; Yakushoku-hatsu No.0208003; 8 Feb 2008)
Q&A on Guideline for Quality and Safety Assurance of Pharmaceuticals and Medical Devices Based on Human Autologous Cells or Tissues  [in Japanese]
(Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, MHLW; 12 Mar 2008)
Concepts for Manufacturing Control and Quality Control of Pharmaceuticals and Medical Devices Based on Human Autologous Cells or Tissues  [in Japanese]
(Notification of Compliance and Narcotics Division, Pharmaceutical and Food Safety Bureau, MHLW; Yakushokukanma-hatsu No.0327025; 27 Mar 2008)
Related to Quality and Safety Assurance of Pharmaceuticals and Medical Devices Based on Human Allogenic Cells or Tissues
[Guideline for Quality and Safety Assurance of Pharmaceuticals and Medical Devices Based on Human Allogenic Cells or Tissues]  [in Japanese]
(Notification of Pharmaceutical and Food Safety Bureau, MHLW; Yakushoku-hatsu No.0912006; 12 Sep 2008)
Q&A on Guideline for Quality and Safety Assurance of Pharmaceuticals and Medical Devices Based on Human Allogenic Cells or Tissues  [in Japanese]
(Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, MHLW; 3 Oct 2008)
• Related to Operation of Guideline for Human Stem Cell Therapy Clinical Research  [in Japanese]
(Notification of Health Service Bureau, MHLW; Ken-hatsu No.0703003; 3 Jul. 2006)
• Guideline for Human Stem Cell Therapy Clinical Research  [in Japanese]
(Ministerial Notification of MHLW; 2006 No.425; 3 Jul. 2006)
• Q&A on "Guideline for Human Stem Cell Therapy Clinical Research  [in Japanese]
(Specific Disease Control Division, Health Service Bureau, MHLW)
• Processes for Human Stem Cell Therapy Clinical Research  [in Japanese]
(Report for HSC, MHLW; 18 May 2006)
• Processes for Evaluation of Human Stem Cell Therapy Clinical Research Based on "Guideline for Human Stem Cell Therapy Clinical Research"  [in Japanese]
(Report for HSC, MHLW; 27 Jul. 2006)
• Related Links on "Guideline for Human Stem Cell Therapy Clinical Research"  [in Japanese]
(Specific Disease Control Division, Health Service Bureau, MHLW)
• Guideline for Establishment and Distribution of Human ES Cells [in Japanese]
（Ministerial Notification of MEXT; 2009 No.156; 21 Aug. 2009）
• Guideline for Use of Human ES Cells [in Japanese]
（Ministerial Notification of MEXT; 2009 No.157; 21 Aug. 2009）
o *Related Web Page Approach to Life Ethics in Life Sciences, Life Science Agora, MEXT  [in Japanese]
• Public Health Guideline on Infectious Disease Issues in Xenotransplantation  [in English]
(Notification of Research and Development Division, Health Policy Bureau, MHLW; Iseiken-hatsu No.0709001; 9 Jul. 2002)
• 「異種移植の実施に伴う公衆衛生上の感染症問題に関する指針」に基づく3T3J2株及び3T3NIH株をフィーダー細胞として利用する上皮系の再生医療への指針について
(Notification of Research and Development Division, Health Policy Bureau, MHLW; Iseiken-hatsu No.0702001; 2 Jul. 2004)
Notification   Guideline   [all in Japanese]

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Standards for Biological Materials
• Standards for Biological Materials [in Japanese]
－Provisions for Transfusion Blood Products, Provisions for Plasma Fraction Products,
Standards for Human Cell and Tissue Materials, Standards for Human Urine Derived Materials,
Standards for Human Derived Materials, Standards for Ruminant Animal Derived Materials,
Standards for Animal Cell and Tissue Materials, Standards for Animal Derived Materials
(Ministerial Notification of MHLW, 2003 No.210; 20 May 2003)
(Ministerial Notification of MHLW, 2004 No.157; Amendments on 30 Mar. 2004)
(Ministerial Notification of MHLW, 2004 No.262; Amendments on 5 Jul. 2004)
(Ministerial Notification of MHLW, 2005 No.177; Amendments on 31 Mar. 2005)
• Considerations in Standards for Biological Materials  [in Japanese]
(Notification of Evaluation and Licensing Division, Safety Division, Compliance and Narcotics Division and Blood and Blood Products Division, Pharmaceutical and Medical Safety Bureau, MHLW; Iyakushin-hatsu No.0520001, Iyakuan-hatsu No.0520001, Iyakukanma-hatsu No.0520001 & iyakuketsu-hatsu No.0520001; 20 May 2003)
The Japanese Pharmacopoeia General Information
• Basic Requirements for Viral Safety of Biotechnological/Biological Products listed in Japanese Pharmacopoeia  [in English]
• Qualification of Animals as Origin of Animal-derived Medicinal Products Provided in the General Notices 39 of Japanese Pharmacopoeia and Other Standards  [in English]
(From The Japanese Pharmacopoeia Fourteen Edition Supplement I [Ministerial Notification of MHLW; 2002 No.395; 27 Dec. 2002])
Special Zones for Structural Reform (Highly Advanced Medical Treatments including Gene and Cellular Therapies)
• Regulations Related to "Law on Special Zones for Structural Reform"
To Web Page of the Headquarters for the Promotion of Special Zones for Structural Reform, Prime Minister of Japan and his Cabinet
• 構造改革特別区域法第18条第1項に規定する高度医療の提供を行う病院又は診療所の構造設備、その有する人員等に関する基準  [in Japanese]
(Ordinance of MHLW; 2004 No.145; 30 Sep. 2004)
• 構造改革特別区域法第18条第1項に規定する高度な医療に関する指針  [in Japanese]
(Ministerial Notification of MHLW; 2004 No.362; 30 Sep. 2004)
• 構造改革特別区域法の一部を改正する法律において新設された医療法等の特例の運用について  [in Japanese]
(Notification of Health Policy Bureau, MHLW; ; Isei-hatsu No.093001; 30 Sep. 2004)