Page 44 - 2023 Taiwan Food and Drug Administration Annual Report
P. 44
2023 Taiwan Food and
Drug Administration
Annual Report
Tip station ▍ Implementation Strategy
The spirit of NCE-2 is: I. Announcement of the
The medicine is approved by the A10 “Regenerative Medicinal
countries regulatory management Products Act (draft)”
units and has been approved
for listing for a long time. Those TFDA announced the “Regenerative
medicines usually have considerable Medicinal Products Act (draft)” on January
technical information on quality, 13, 2022. The Act covers the whole
safety, and effectiveness, and with lifecycle management of regenerative
experience in human use after the medicinal products, including product
medicine has been on the market for registration, conditional approval, and
a long time. It should be reasonably specific requirements on the manufacture,
applicable to support the safety and distribution, and post-marketing management
effectiveness of drugs with the same of regenerative medicinal products for the
ingredients. industry, aiming to promote the development
of the biotechnology industry in Taiwan.
42 In addition, TFDA continues to establish
relevant review guidances for regenerative
medicinal products as a reference for research
and development for the industry, improving
the regulatory environment for regenerative
medicinal products.
II. Amendment of the “Key
Points of Review for new
chemical entities (excluding
biological medicinal
products) that have been
approved for market in A10
countries for over 5 years”
(NCE-2)
In order for the general public to have
access to new chemical entities as early as
possible, with the quality, safety, and efficacy
