Page 44 - 2018食藥署年報(英文版)

To keep up with the emerging biotechnologies and ensure product safety and efficacy of
regenerative medicines, TFDA actively develop regulations for the management of advanced
biotechnology, and construct a specified regulatory framework for regenerative medicines based
on the heterogeneity of regenerative medicinal products and its complexity in clinical applications
and specialty in manufacturing processes. This regulatory framework is expected to achieve an
independent and straight forward management on regenerative medicinal products.

Implementation Measures

1. Advancement of pharmaceutical clinical trial review process

The TFDA released three “Advancement Measures for Pharmaceutical Clinical Trial
Protocol Review Process” on August 10, 2017. The details are as follows:
(1) Simplify the review process of “First-in-human medicinal products” clinical trials review
process, i.e. change the review process from “consult with external experts case-by-case
and forward to advisory committee meeting for further discussion if needed” to “reviewed

by Center for Drug Evaluation (CDE) and consult with external experts if needed;
forward to advisory committee meeting for further discussion if any further issue exists,”
to shorten the case-by-case consultation period.
(2) Establish the “Expedited Review Track for Regenerative Medicinal Product Clinical Trials,”
introduce a 30-day expedited review track for multinational (must be carried out at least in
one of the 10 medically advanced countries, multicenter, non-first in human trials, and for
investigator-initiated clinical trials which the regenerative medicinal product has been used
in other clinical trials conducted in Taiwan and manufactured by the same laboratory with
identical manufacturing processes for academic purposes, to encourage the development of

emerging regenerative medicinal products in Taiwan.
(3) Refine the review process of clinical trial protocol amendments based on the risk levels
and implement diverse review flows (i.e. technical review, administrative review, and
retained by the applicant for future inspection) to enhance the review efficiency.

2. Refuse-to-file for the application of drug registration

The refuse-to-file (RTF) scheme for the application of drug registration was initiated
since 2017 in order to strengthen the review efficiency. Upon submission for registration, the
submission will be rejected if the applicant (1) fails to provide complete administrative documents
in accordance with the Regulations for Registration of Medicinal Products; or (2) fails to provide
complete technical documents in accordance with the format stipulated in the Common Technical
Documents (CTD); or (3) fails to pay the submission fee based on the Fee Charging Standards for
Registration of Western Medicinal Products and Medical Devices.

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