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Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea.
Adv Exp Med Biol. 2015; 871:163-79.AE

Abstract

The Ministry of Food and Drug Safety regulates gene therapy and cell therapy products as biological products under the authority of the Pharmaceutical Affairs Act. As with other medicinal products, gene therapy and cell therapy products are subject to approval for use in clinical trials and for a subsequent marketing authorization and to post-market surveillance. Research and development of gene therapy and cell therapy products have been progressing rapidly in Korea with extensive investment, offering great potential for the treatment of various serious diseases. To facilitate development of safe and effective products and provide more opportunities to patients suffering from severe diseases, several regulatory programs, such as the use of investigational products for emergency situations, fast-track approval, prereview of application packages, and intensive regulatory consultation, can be applied to these products. The regulatory approach for these innovative products is case by case and founded on science-based review that is flexible and balances the risks and benefits.

Authors+Show Affiliations

Cell and Gene Therapy Products Division, National Institute of Food and Drug Safety (NIFDS), Ministry of Food and Drug Safety (MFDS), 187 Osongsaengmyeong 2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 361-951, South Korea.Cell and Gene Therapy Products Division, National Institute of Food and Drug Safety (NIFDS), Ministry of Food and Drug Safety (MFDS), 187 Osongsaengmyeong 2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 361-951, South Korea.Cell and Gene Therapy Products Division, National Institute of Food and Drug Safety (NIFDS), Ministry of Food and Drug Safety (MFDS), 187 Osongsaengmyeong 2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 361-951, South Korea.Cell and Gene Therapy Products Division, National Institute of Food and Drug Safety (NIFDS), Ministry of Food and Drug Safety (MFDS), 187 Osongsaengmyeong 2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 361-951, South Korea.Cell and Gene Therapy Products Division, National Institute of Food and Drug Safety (NIFDS), Ministry of Food and Drug Safety (MFDS), 187 Osongsaengmyeong 2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 361-951, South Korea. wshin@korea.kr.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

26374218

Citation

Choi, Minjoung, et al. "Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea." Advances in Experimental Medicine and Biology, vol. 871, 2015, pp. 163-79.
Choi M, Han E, Lee S, et al. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea. Adv Exp Med Biol. 2015;871:163-79.
Choi, M., Han, E., Lee, S., Kim, T., & Shin, W. (2015). Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea. Advances in Experimental Medicine and Biology, 871, 163-79. https://doi.org/10.1007/978-3-319-18618-4_9
Choi M, et al. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea. Adv Exp Med Biol. 2015;871:163-79. PubMed PMID: 26374218.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea. AU - Choi,Minjoung, AU - Han,Euiri, AU - Lee,Sunmi, AU - Kim,Taegyun, AU - Shin,Won, PY - 2015/9/17/entrez PY - 2015/9/17/pubmed PY - 2015/12/30/medline KW - Cell therapy KW - Gene therapy KW - Guideline KW - Ministry of Food and Drug Safety KW - Regulation KW - Regulatory oversight SP - 163 EP - 79 JF - Advances in experimental medicine and biology JO - Adv Exp Med Biol VL - 871 N2 - The Ministry of Food and Drug Safety regulates gene therapy and cell therapy products as biological products under the authority of the Pharmaceutical Affairs Act. As with other medicinal products, gene therapy and cell therapy products are subject to approval for use in clinical trials and for a subsequent marketing authorization and to post-market surveillance. Research and development of gene therapy and cell therapy products have been progressing rapidly in Korea with extensive investment, offering great potential for the treatment of various serious diseases. To facilitate development of safe and effective products and provide more opportunities to patients suffering from severe diseases, several regulatory programs, such as the use of investigational products for emergency situations, fast-track approval, prereview of application packages, and intensive regulatory consultation, can be applied to these products. The regulatory approach for these innovative products is case by case and founded on science-based review that is flexible and balances the risks and benefits. SN - 0065-2598 UR - https://www.unboundmedicine.com/medline/citation/26374218/Regulatory_Oversight_of_Gene_Therapy_and_Cell_Therapy_Products_in_Korea_ L2 - https://dx.doi.org/10.1007/978-3-319-18618-4_9 DB - PRIME DP - Unbound Medicine ER -