Page 31 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report Chapter 2. Legal Environment and Registration

(BA) and bioequivalence (BE) study results must be provided as attachments for

inspection and registration applications, the corresponding study protocols and reports
must be reviewed and approved as well. The number of drug permit licenses approved by
TFDA every year is listed in Table 2 of Annex II.

A. Pre-market registration of medicinal products
A total of 136 new drug permit licenses approved by TFDA in 2016 (Figure 2-5).
Among 136 new drug applications (NDA), 44 involve new drugs containing new
chemical entities (NCE) and 29 NDAs are biologics. Therapeutic areas include
anti-cancer drugs, anti-HCV or anti-HIV drugs, drugs for rare diseases, and

vaccines (e.g. DTaP-Hib-IPV and quadrivalent influenza vaccines) required by
public health services to benefit those expecting new treatment options.

B. Clinical trial reviews
(A) Revisions were conducted according to the “Application Guidelines for the
Clinical Trial of Medicinal Products” and “Ethical Review for the Clinical
Trial of Medicinal Products (Central IRB)” to ensure the comprehensiveness

of documents submitted by the applicants and improve the efficiency of case
review processes.

cases

year

Figure 2-5 Number of new drugs approved throughout the years

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