Chapter title |
Regulation of Cell and Gene Therapy Medicinal Products in Taiwan
|
---|---|
Chapter number | 10 |
Book title |
Regulatory Aspects of Gene Therapy and Cell Therapy Products
|
Published in |
Advances in experimental medicine and biology, January 2015
|
DOI | 10.1007/978-3-319-18618-4_10 |
Pubmed ID | |
Book ISBNs |
978-3-31-918617-7, 978-3-31-918618-4
|
Authors |
Lin, Yi-Chu, Wang, Po-Yu, Tsai, Shih-Chih, Lin, Chien-Liang, Tai, Hsuen-Yung, Lo, Chi-Fang, Wu, Shiow-Ing, Chiang, Yu-Mei, Liu, Li-Ling, 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 |
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. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
United States | 1 | 100% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Scientists | 1 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 20 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 4 | 20% |
Student > Ph. D. Student | 4 | 20% |
Student > Bachelor | 2 | 10% |
Student > Postgraduate | 2 | 10% |
Student > Master | 1 | 5% |
Other | 1 | 5% |
Unknown | 6 | 30% |
Readers by discipline | Count | As % |
---|---|---|
Nursing and Health Professions | 3 | 15% |
Agricultural and Biological Sciences | 3 | 15% |
Social Sciences | 2 | 10% |
Engineering | 2 | 10% |
Medicine and Dentistry | 2 | 10% |
Other | 2 | 10% |
Unknown | 6 | 30% |