Regulation of Cell and Gene Therapy Medicinal Products in Taiwan

Yi-Chu Lin; Po-Yu Wang; Shih-Chih Tsai; Chien-Liang Lin; Hsuen-Yung Tai; Chi-Fang Lo; Shiow-Ing Wu; Yu-Mei Chiang; Li-Ling Liu

doi:10.1007/978-3-319-18618-4_10

Regulation of Cell and Gene Therapy Medicinal Products in Taiwan

Adv Exp Med Biol. 2015:871:181-94. doi: 10.1007/978-3-319-18618-4_10.

Authors

Yi-Chu Lin¹, Po-Yu Wang², Shih-Chih Tsai³, Chien-Liang Lin⁴, Hsuen-Yung Tai⁵, Chi-Fang Lo⁶, Shiow-Ing Wu⁷, Yu-Mei Chiang⁸, Li-Ling Liu⁹

Affiliations

¹ Division of Medicinal Products, Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. yclin@fda.gov.tw.
² Division of Medicinal Products, Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. poywang@fda.gov.tw.
³ Division of Medicinal Products, Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. tsaisc@fda.gov.tw.
⁴ Division of Medicinal Products, Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. jllin@fda.gov.tw.
⁵ Division of Medicinal Products, Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. pmarytai@fda.gov.tw.
⁶ Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. cflo@fda.gov.tw.
⁷ Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. shiow@fda.gov.tw.
⁸ Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. cymei@fda.gov.tw.
⁹ Division of Medicinal Products, Taiwan Food and Drug Administration, 161-2, Kunyang Street, Nangang, Taipei, 11561, Taiwan. LLL@fda.gov.tw.

PMID: 26374219
DOI: 10.1007/978-3-319-18618-4_10

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.

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).

Publication types

Review

MeSH terms

Animals
Cell- and Tissue-Based Therapy / ethics*
Cell- and Tissue-Based Therapy / methods
Clinical Trials as Topic
Drug Evaluation, Preclinical / methods
Drug and Narcotic Control / legislation & jurisprudence*
Genetic Therapy / ethics
Genetic Therapy / legislation & jurisprudence*
Humans
Investigational New Drug Application / legislation & jurisprudence*
Marketing / legislation & jurisprudence
Patient Safety / legislation & jurisprudence
Practice Guidelines as Topic
Quality Control
Research Design
Taiwan
Translational Research, Biomedical / ethics
Translational Research, Biomedical / legislation & jurisprudence*