Update on Regulation of Regenerative Medicine in Taiwan.

Autor:	Chao WY; Taiwan Food and Drug Administration, Taipei, Taiwan., Chang YT; Taiwan Food and Drug Administration, Taipei, Taiwan., Tsai YT; Taiwan Food and Drug Administration, Taipei, Taiwan., Huang MC; Taiwan Food and Drug Administration, Taipei, Taiwan., Lin YC; Taiwan Food and Drug Administration, Taipei, Taiwan., Wu MM; Taiwan Food and Drug Administration, Taipei, Taiwan., Chi JF; Taiwan Food and Drug Administration, Taipei, Taiwan., Lin CL; Taiwan Food and Drug Administration, Taipei, Taiwan., Cheng HF; Taiwan Food and Drug Administration, Taipei, Taiwan., Wu SM; Taiwan Food and Drug Administration, Taipei, Taiwan. shmewu@fda.gov.tw.
Jazyk:	angličtina
Zdroj:	Advances in experimental medicine and biology [Adv Exp Med Biol] 2023; Vol. 1430, pp. 211-219.
DOI:	10.1007/978-3-031-34567-8_12
Abstrakt:	Due to rapid development of biotechnology in recent years, the field of regenerative medicine has attracted considerable attention. Regenerative medicine-related regulations have been established in several countries to ensure the quality, safety, and efficacy of innovative treatments. Considering the diversity of regenerative medicine, the regulatory framework in Taiwan has been adjusted in response to global trend and local demand. Before 2010, cell and gene therapies were regarded as "new medical practice" under the "Medical Care Act." Along with the establishment of Taiwan Food and Drug Administration (TFDA) in 2010, regenerative medicine was regulated as "medicinal products" under the "Pharmaceutical Affairs Act." Then, the Ministry of Health and Welfare (MOHW) established a new dual-track regulatory pathway for regenerative medicine in 2016. The dual-track pathway divided regenerative medicine into medical practices and medicinal products, aiming to improve the accessibility of new treatments to patients and maintain the flexibility for clinical operations. In order to refine the regulation, the MOHW proposed two draft Acts for regenerative medicine in 2022. The two draft Acts are currently under legislative process. It is expected that the research and development of regenerative medicine can be further accelerated, thus providing early access to innovative therapies for patients in the future. (© 2023. The Author(s), under exclusive license to Springer Nature Switzerland AG.)
Databáze:	MEDLINE
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