title: Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea.
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.affiliation: 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.
authors.forename: Minjoung
authors.initials: M
authors.lastname: Choi
authors.affiliation: 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.
authors.forename: Euiri
authors.initials: E
authors.lastname: Han
authors.affiliation: 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.
authors.forename: Sunmi
authors.initials: S
authors.lastname: Lee
authors.affiliation: 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.
authors.forename: Taegyun
authors.initials: T
authors.lastname: Kim
authors.affiliation: 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.
authors.forename: Won
authors.initials: W
authors.lastname: Shin
mesh_terms: D000818:Animals; D064987:Cell- and Tissue-Based Therapy / Q000941:ethics* / Q000379:methods; D002986:Clinical Trials as Topic; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D015316:Genetic Therapy / Q000941:ethics / Q000331:legislation & jurisprudence*; D006801:Humans; D017387:Investigational New Drug Application / Q000331:legislation & jurisprudence*; D040541:Marketing / Q000331:legislation & jurisprudence*; D061214:Patient Safety / Q000331:legislation & jurisprudence; D017410:Practice Guidelines as Topic; D011786:Quality Control; D056910:Republic of Korea; D012107:Research Design; D057170:Translational Research, Biomedical / Q000941:ethics / Q000331:legislation & jurisprudence*
keywords: Cell therapy; Gene therapy; Guideline; Ministry of Food and Drug Safety; Regulation; Regulatory oversight