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Regulation of Cell and Gene Therapy Medicinal Products in Taiwan.
Adv Exp Med Biol. 2015; 871:181-94.AE

Abstract

Owing to the rapid and mature development of emerging biotechnology in the fields of cell culture, cell preservation, and recombinant DNA technology, more and more cell or gene medicinal therapy products have been approved for marketing, to treat serious diseases which have been challenging to treat with current medical practice or medicine. This chapter will briefly introduce the Taiwan Food and Drug Administration (TFDA) and elaborate regulation of cell and gene therapy medicinal products in Taiwan, including regulatory history evolution, current regulatory framework, application and review procedures, and relevant jurisdictional issues. Under the promise of quality, safety, and efficacy of medicinal products, it is expected the regulation and environment will be more flexible, streamlining the process of the marketing approval of new emerging cell or gene therapy medicinal products and providing diverse treatment options for physicians and patients.

Authors+Show Affiliations

Division of Medicinal Products, Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. yclin@fda.gov.tw.Division of Medicinal Products, Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. poywang@fda.gov.tw.Division of Medicinal Products, Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. tsaisc@fda.gov.tw.Division of Medicinal Products, Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. jllin@fda.gov.tw.Division of Medicinal Products, Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. pmarytai@fda.gov.tw.Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. cflo@fda.gov.tw.Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. shiow@fda.gov.tw.Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. cymei@fda.gov.tw.Division of Medicinal Products, Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. LLL@fda.gov.tw.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

26374219

Citation

Lin, Yi-Chu, et al. "Regulation of Cell and Gene Therapy Medicinal Products in Taiwan." Advances in Experimental Medicine and Biology, vol. 871, 2015, pp. 181-94.
Lin YC, Wang PY, Tsai SC, et al. Regulation of Cell and Gene Therapy Medicinal Products in Taiwan. Adv Exp Med Biol. 2015;871:181-94.
Lin, Y. C., Wang, P. Y., Tsai, S. C., Lin, C. L., Tai, H. Y., Lo, C. F., Wu, S. I., Chiang, Y. M., & Liu, L. L. (2015). Regulation of Cell and Gene Therapy Medicinal Products in Taiwan. Advances in Experimental Medicine and Biology, 871, 181-94. https://doi.org/10.1007/978-3-319-18618-4_10
Lin YC, et al. Regulation of Cell and Gene Therapy Medicinal Products in Taiwan. Adv Exp Med Biol. 2015;871:181-94. PubMed PMID: 26374219.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Regulation of Cell and Gene Therapy Medicinal Products in Taiwan. AU - Lin,Yi-Chu, AU - Wang,Po-Yu, AU - Tsai,Shih-Chih, AU - Lin,Chien-Liang, AU - Tai,Hsuen-Yung, AU - Lo,Chi-Fang, AU - Wu,Shiow-Ing, AU - Chiang,Yu-Mei, AU - Liu,Li-Ling, PY - 2015/9/17/entrez PY - 2015/9/17/pubmed PY - 2015/12/30/medline KW - Cell therapy medicinal products KW - Clinical trials KW - Gene therapy medicinal products KW - Investigational New Drug (IND) KW - Medical practice KW - Medicinal products KW - New Drug Application (NDA) KW - New medical practice KW - Points to consider KW - TFDA Guidance KW - Taiwan Food and Drug Administration (TFDA) SP - 181 EP - 94 JF - Advances in experimental medicine and biology JO - Adv. Exp. Med. Biol. VL - 871 N2 - Owing to the rapid and mature development of emerging biotechnology in the fields of cell culture, cell preservation, and recombinant DNA technology, more and more cell or gene medicinal therapy products have been approved for marketing, to treat serious diseases which have been challenging to treat with current medical practice or medicine. This chapter will briefly introduce the Taiwan Food and Drug Administration (TFDA) and elaborate regulation of cell and gene therapy medicinal products in Taiwan, including regulatory history evolution, current regulatory framework, application and review procedures, and relevant jurisdictional issues. Under the promise of quality, safety, and efficacy of medicinal products, it is expected the regulation and environment will be more flexible, streamlining the process of the marketing approval of new emerging cell or gene therapy medicinal products and providing diverse treatment options for physicians and patients. SN - 0065-2598 UR - https://www.unboundmedicine.com/medline/citation/26374219/Regulation_of_Cell_and_Gene_Therapy_Medicinal_Products_in_Taiwan_ L2 - https://dx.doi.org/10.1007/978-3-319-18618-4_10 DB - PRIME DP - Unbound Medicine ER -