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Regulatory Frameworks for Gene and Cell Therapies in Japan.
Adv Exp Med Biol. 2015; 871:147-62.AE

Abstract

The regulations for the human use of advanced therapy medical products such as gene and cell therapy products have evolved in accordance with advance of clinical experience, scientific knowledge, and social acceptance to these technologies. In Japan, two laws, the Pharmaceuticals and Medical Devices (PMD) Act and the Act on the Safety of Regenerative Medicine (ASRM), were enacted in November 2014. The PMD Act defines regenerative medical products for the first time and introduces a system for the conditional and time-limited marketing authorization of regenerative medical products. Under ASRM, the responsibilities of medical institutions to ensure the safety and provide transparency of such medical technologies are described. Amendments to accompanying guidelines for these two Acts are currently in preparation. It is expected that the new legislative frameworks will promote the timely development of new products and technologies, to bring safe and effective regenerative medicines to Japanese patients.

Authors+Show Affiliations

Office of Cellular and Tissue-Based Products (OCTP), Pharmaceuticals and Medical Devices Agency (PMDA), 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan. maeda-daisuke@pmda.go.jp.Office of Cellular and Tissue-Based Products (OCTP), Pharmaceuticals and Medical Devices Agency (PMDA), 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan. yamaguchi-teruhide@pmda.go.jp.Office of New Drug V, Pharmaceuticals and Medical Devices Agency (PMDA), 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan. ishizuka-takami@pmda.go.jp.Division of Pharmaceutical Affairs Consultation, Kansai Branch, Pharmaceuticals and Medical Devices Agency (PMDA), 3-1, Ofuka-cho, Kita-ku, Osaka, 530-0011, Japan. hirata-masakazu@pmda.go.jp.Office of Cellular and Tissue-Based Products (OCTP), Pharmaceuticals and Medical Devices Agency (PMDA), 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan. takekita-kazuhiro@pmda.go.jp.Office of Cellular and Tissue-Based Products (OCTP), Pharmaceuticals and Medical Devices Agency (PMDA), 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan. sato-daisauku@pmda.go.jp.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

26374217

Citation

Maeda, Daisuke, et al. "Regulatory Frameworks for Gene and Cell Therapies in Japan." Advances in Experimental Medicine and Biology, vol. 871, 2015, pp. 147-62.
Maeda D, Yamaguchi T, Ishizuka T, et al. Regulatory Frameworks for Gene and Cell Therapies in Japan. Adv Exp Med Biol. 2015;871:147-62.
Maeda, D., Yamaguchi, T., Ishizuka, T., Hirata, M., Takekita, K., & Sato, D. (2015). Regulatory Frameworks for Gene and Cell Therapies in Japan. Advances in Experimental Medicine and Biology, 871, 147-62. https://doi.org/10.1007/978-3-319-18618-4_8
Maeda D, et al. Regulatory Frameworks for Gene and Cell Therapies in Japan. Adv Exp Med Biol. 2015;871:147-62. PubMed PMID: 26374217.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Regulatory Frameworks for Gene and Cell Therapies in Japan. AU - Maeda,Daisuke, AU - Yamaguchi,Teruhide, AU - Ishizuka,Takami, AU - Hirata,Masakazu, AU - Takekita,Kazuhiro, AU - Sato,Daisaku, PY - 2015/9/17/entrez PY - 2015/9/17/pubmed PY - 2015/12/30/medline KW - Act on the safety of regenerative medicine KW - Cell therapy KW - Gene therapy KW - Guidelines KW - Japan KW - Pharmaceuticals and medical devices act SP - 147 EP - 62 JF - Advances in experimental medicine and biology JO - Adv Exp Med Biol VL - 871 N2 - The regulations for the human use of advanced therapy medical products such as gene and cell therapy products have evolved in accordance with advance of clinical experience, scientific knowledge, and social acceptance to these technologies. In Japan, two laws, the Pharmaceuticals and Medical Devices (PMD) Act and the Act on the Safety of Regenerative Medicine (ASRM), were enacted in November 2014. The PMD Act defines regenerative medical products for the first time and introduces a system for the conditional and time-limited marketing authorization of regenerative medical products. Under ASRM, the responsibilities of medical institutions to ensure the safety and provide transparency of such medical technologies are described. Amendments to accompanying guidelines for these two Acts are currently in preparation. It is expected that the new legislative frameworks will promote the timely development of new products and technologies, to bring safe and effective regenerative medicines to Japanese patients. SN - 0065-2598 UR - https://www.unboundmedicine.com/medline/citation/26374217/Regulatory_Frameworks_for_Gene_and_Cell_Therapies_in_Japan_ L2 - https://dx.doi.org/10.1007/978-3-319-18618-4_8 DB - PRIME DP - Unbound Medicine ER -