Page 45 - 2019食藥署年報(英文版)

match the purchased data, after being judged to be in compliance with the regulations, it can be
released.

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of regenerative medicinal products, the current regulations cannot be fully applied. Through
the promotion of the special law of the Pharmaceutical Affairs Act, it is expected to help to
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Pharmaceutical Affairs Act, in order to improve the regulatory environment for the total product
life cycle management of regenerative medicinal products. At present, Regenerative Medicinal
Products Derivative Act (Draft) has been reviewed by the Legislative Yuan. We look forward
to the early completion of legislation to provide more and more innovative treatment options for
patients and to promote the vigorous development of Taiwan’s biotechnology industry chain.

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in NDA review, TFDA reinforces the review and two-way communication with the industries.

TFDA is expected that new drugs can be quickly approved to be on the market by promoting the
concept of management system for NDA. The number of accomplished and received cases and
review time of NDA are shown in Figure 3-1.

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