Page 44 - 2019食藥署年報(英文版)

released the "Regenerative Medicinal Products Derivative Act (Draft) RQ -XO\
and it was subsequently passed by the Executive Yuan on October 18, 2018 and sent to the
Legislative Yuan for consideration. It established a rigorous "pre-market review and post-market
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safety of the regenerative medicinal products, and the manufacturers also have to comply with
the Good Manufacturers Practice (PIC/S GMP) with TFDA approval prior to the availability of
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products as well as to maintain the patients’ treatment rights.

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efficiency and transparency of the NDA review, including the announcement of "Key Points
of NDA Review," "NDA Review Process and Time Management," and promotion of “refuse to
¿OH 57) D QHZ GUXJ DSSOLFDWLRQ" etc. In addition, the "Checklist of Refuse to File (RTF) for
New Drug Application" was announced in 2018, to clarify the information required for NDA;
it is expected to enhance review efficiency by improving the quality of submitted materials.
To fulfill unmet medical need, expedited NDA review processes were announced, including

the "Abbreviated review" "priority review" and "Accelerative review." In 2018, "Designation
of Breakthrough Therapy" was announced, which is aimed to accelerate new drug approval of
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treatments. Through early stage regulatory consultation and of technical issue consoling, the
listing of drugs was accelerated.

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TFDA enacted the amendments to the provisions of the "Regulations for the Inspection and
Examination of Imported Medicaments" on August 22, 2018. The provisions clearly stipulate
that inspection items at borders include the active pharmaceutical ingredients listed in Chapter
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random inspections by batches shall be implemented. Enhance the management of imported

active pharmaceutical ingredients and the accuracy of customs clearance, to prevent any illegal
related activities and stop narcotics from entering the nation.
TFDA had purchased 14 Raman Spectrometers, to conduct border inspections and
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and according to the risk judgment, the batch inspection is carried out. The chosen one will be
quickly inspected with the instrument whether the imported active pharmaceutical ingredients
42