title: Regulation of Cell and Gene Therapy Medicinal Products in Taiwan.
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.affiliation: Division of Medicinal Products, Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. yclin@fda.gov.tw.
authors.forename: Yi-Chu
authors.initials: YC
authors.lastname: Lin
authors.affiliation: Division of Medicinal Products, Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. poywang@fda.gov.tw.
authors.forename: Po-Yu
authors.initials: PY
authors.lastname: Wang
authors.affiliation: Division of Medicinal Products, Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. tsaisc@fda.gov.tw.
authors.forename: Shih-Chih
authors.initials: SC
authors.lastname: Tsai
authors.affiliation: Division of Medicinal Products, Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. jllin@fda.gov.tw.
authors.forename: Chien-Liang
authors.initials: CL
authors.lastname: Lin
authors.affiliation: Division of Medicinal Products, Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. pmarytai@fda.gov.tw.
authors.forename: Hsuen-Yung
authors.initials: HY
authors.lastname: Tai
authors.affiliation: Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. cflo@fda.gov.tw.
authors.forename: Chi-Fang
authors.initials: CF
authors.lastname: Lo
authors.affiliation: Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. shiow@fda.gov.tw.
authors.forename: Shiow-Ing
authors.initials: SI
authors.lastname: Wu
authors.affiliation: Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. cymei@fda.gov.tw.
authors.forename: Yu-Mei
authors.initials: YM
authors.lastname: Chiang
authors.affiliation: Division of Medicinal Products, Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. LLL@fda.gov.tw.
authors.forename: Li-Ling
authors.initials: LL
authors.lastname: Liu
mesh_terms: D000818:Animals; D064987:Cell- and Tissue-Based Therapy / Q000941:ethics* / Q000379:methods; D002986:Clinical Trials as Topic; D004353:Drug Evaluation, Preclinical / Q000379:methods; 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; D012107:Research Design; D013624:Taiwan; D057170:Translational Research, Biomedical / Q000941:ethics / Q000331:legislation & jurisprudence*
keywords: Cell therapy medicinal products; Clinical trials; Gene therapy medicinal products; Investigational New Drug (IND); Medical practice; Medicinal products; New Drug Application (NDA); New medical practice; Points to consider; TFDA Guidance; Taiwan Food and Drug Administration (TFDA)