Page 43 - 2019食藥署年報(英文版)

"EWBODFNFOU PG %SVH

03c
.BOBHFNFOU

To implement total product life cycle management of drugs, effectively guarantee the
TXDOLW\ VDIHW\ DQG HI¿FDF\ RI GUXJV 7)'$ DFWLYHO\ SDUWLFLSDWHV LQ LQWHUQDWLRQDO RUJDQL]DWLRQV
improves drug management regulations to be in line with the international standards and
promote the development and competitiveness of the domestic pharmaceutical industry. In
addition, TFDA continuously improves the inspection and management system for drugs, safety
quality monitoring and trace and track system to strengthen drug risk management and provide

a safe consumption environment for people to use drugs.

4FDUJPO *NQSPWF UIF %SVH 3FHVMBUPSZ .BOBHFNFOUFDUJPO
4

0
0SJHJO PG 1PMJDZSJHJO PG 1PMJDZ
In view of the rapid development of emerging biotechnology, and cell or gene therapy

products on the international market, Taiwan listed regenerative medicine as one of the key
points of the "Biomedical Industry Innovation Promotion Program" since 2016. TFDA also
actively promoted regenerative medical regulations to improve the regulatory management
environment. At the same time, to protect the rights of patients and facilitate the development
of biotechnology industry, TFDA will continuously construct a sound drug review and
management system.

*N
*NQMFNFOUBUJPO .FBTVSFTQMFNFOUBUJPO .FBTVSFT
1SPNPUJOH UIF MFHJTMBUJPO PG UIF TQFDJBM MBX GPS UIF NBOBHFNFOU PG

SFHFOFSBUJWF NFEJDJOBM QSPEVDUT
In compliance with the international management trend and the current development

condition in the domestic pharmaceutical industry, the management structure of regenerative
medicine includes two aspects such as "products" and "medical technology." The authority
units are TFDA and the Department of Medical Affairs, Ministry of Health and Welfare,
respectively. In the management of regenerative medicinal products, TFDA actively promotes
the legislation of the special law of the management of regenerative medicinal products. TFDA
41