Table 4.
Major issuances of the legislation of human cells and tissue products in the US, the EU, and Japan.
| Country or area | Issuance date | Name of legislation | Note |
|---|---|---|---|
| US |
1996 | Guidance on application for Products Comprised of Living Autologous Cells Manipulated Ex Vivo and Intended for Structure Repair or Reconstruction; Availability (Federal Register Vol. 61, No.103 P26523-26524, Notice May 28, 1996) |
First guidance of manipulated autologous (MAS) cells |
| 1997 | Proposed Approach to Regulation of Cellular and Tissue-Based Products; Availability and Public Meeting (Federal Register Vol. 62, No.42 P9721-9722, Proposed Rules March 4, 1997) | Proposed rules of cellular and tissue-based products | |
| 2001 | Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing (Federal Register Vol. 66, No.13 P5447-5469, Final Rules January 19, 2001) | Final rules of establishment registration and listing regarding human cells, tissues and cellular and tissue-based products (HCTPs) | |
| 2004 | Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (Federal Register Vol. 69, No.101 P2978629834, Final Rule May 25, 2004) | Final rules of donors eligibility for HCTPs | |
| Current Good Tissue Practice for Human Cells, Tissues, and Cellular and Tissue-Based Product Establishment; Inspection and Enforcement (Federal Register Vol. 69, No.226 P68612-68688, Final Rule November 24, 2004) | Final rules of inspection and enforcement for current good tissue practice (CGTP) of HCTPs | ||
| 2007 |
Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling (Federal Register Vol. 72, No.117 P33667-33669, Final rule June 19, 2007) |
Final rules of donor screening and testing, and labeling for HCTPs |
|
| EU |
2001 | Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use | Medicinal products directive regarding to GMP- and GCP-compliance, advertising, labeling, classification and distribution |
| 2004 | Regulation (EC) 726/2004 of the European Parliament and the Council of 31 March 2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency | Medicinal products for human use regarding to EU-wide marketing authorization | |
| 2007 | Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 Official Journal of the European Union (L324/121) Dec.10, 2007 |
Advanced therapy medicinal products (ATMP), ATMP definition, ATMP complying with existing market authorization requirements and the post-marketing pharmacovigilance rules, a new Committee for Advanced Therapies (CAT)’s responsibilities | |
| 2009 | Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products | ||
| Commission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and nonclinical data relating to advanced therapy medicinal products developed by micro, small, medium-sized enterprises |
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| Japan | 1999 | Quality and safety assurance for medical devices or drug products using cells or tissues. (Iyakuhatsu: PFSB notification No. 906 of July 30, 1999) (in Japanese) | Confirming application prior to initiating clinical trial. Records and documents retention of specified biologics for 30 years and biologics for 10 years |
| 2000 | Quality and safety assurance for drug products manufactured using human- or animal-derived components as raw materials, Appendix 1: Basic policies for handling and using drug products using cells and tissue; Appendix 2: Guidance regarding quality and safety assurance for drug products manufactured by processing human-derived cells and tissue. (Iyakuhatsu: PFSB notification No. 1314 of December 26, 2000) (in Japanese) | Specifying notification regarding quality and safety assurance for drug products manufactured by processing human-derived cells and tissue | |
| 2004 | Guidance of regenerative medicine for epidermis using 3T3J2 and 3T3NIH as feeder cells with regard to guidance of infectious issues for public health conducting xenotransplantation.(Iseikenhatsu: MHLW/HPB/RDD notification No. 0702001 of July 2, 2004) (in Japanese) | Notification of regenerative medicine for epidermis using 3T3J2 and 3T3NIH as feeder cells | |
| 2008 | Quality and safety assurance for drug products or medical devices with processed (autologous) human-derived cells and tissue (Yakushokuhatsu: MHLW/PFSB notification No. 0208003 of February 8, 2008) (Partial amendment, Jimurenraku: Administrative notification of September 12, 2008) (in Japanese) | Notification of drugs or medical devices with processed autologous human-derived cells and tissue | |
| Quality and safety assurance for drug products or medical devices with processed (allogeneic) human-derived cells and tissue (Yakushokuhatsu: MHLW/PFSB notification No. 0912006 of September 12, 2008) (in Japanese) | Notification of drugs or medical devices with processed allogeneic human-derived cells and tissue | ||
| 2010 | Partial amendment with regard to quality and safety assurance for medical devices or drug products using cells or tissues. (Yakushoku hatsu: PFSB notification No. 1101-3 of November 1, 2010) (in Japanese) |
Exemption of confirming application prior to initiating clinical trial |
The US: the United States; The EU: the European Union; MAS: Manipulated Autologous; HCTPs: Human Cells, Tissues and Cellular and Tissue-based Products; CGTP: Current Good Tissue Practice; GMP: Good Manufacturing Practice; GCP: Good Clinical Practice; ATMP: Advanced Therapy Medicinal Products; CAT: Committee for Advanced Therapies; MHLW: Ministry of Health, Labour and Welfare. PFSB: Pharmaceutical and Food Safety Bureau; HPB: Health Policy Bureau; RDD: Research and Development Division.