Page 45 - 2018食藥署年報(英文版)

3. Electronic submission and online application platform for

review of medicinal products

In order to harmonized with international standards, the paper-less application and review
system of medicinal products procedure has been step wisely implemented since 2015, while
submissions using paper-based copies and CDs are gradually reduced with the establishment of
e-submission platform. The paper-less pharmaceutical management system was refined in 2018
and firstly implemented on the applications of license extension and cancellation, and the on-line
submission system is design to be gradually integrated with the official documentation system.
The comprehensive E-service system is expected to be fully implemented in 2020 and further
enhance the review efficiency and to help the subsequent real-time data inquiries and updates.

4. Management of regenerative medicinal products

TFDA stipulated a draft of “Regenerative Medicinal Product Ordinance” in 2017, which
clearly defines the regulatory scope as regenerative medicinal products that are “commercialized,
manufacturing standardized and normalized for the purpose of batch production and marketing

sales.” This regulatory scope is distinguished from the regulation for regenerative medicinal
therapies, which is defined as medical technologies that are “practices clinically performed to
treat certain patient in certain medical institute.” The contents of the draft Ordinance involves
assessment of donor eligibility and informs consents, the management of conditional approval,
post-marketing surveillance and tracking system. The regulatory framework is designed to
ensure the quality, safety, and effectiveness of regenerative medicinal products and protect donor/
patient’s rights for proper treatments. By reinforcing the management policies and escalating the
law hierarchy, it is expected to create a standard for the biomedical/biotechnology industry to
comply with and support the development of regenerative medicine in Taiwan. Legislation of the

Ordinance is expected to be finalized in the end of 2018.

5. Consultation and counseling on medicinal product projects

To facilitate pharmaceutical industry development, encourage novel drug research and

development and provide consultations/counseling on new drugs, biologics, biosimilars, regenerative
medicinal products that are under development or filing for registration, TFDA specifically stipulates
the “Point for Project Consultation for Medicinal Products” to help applicants prepare documents
adequately, and thus accelerate the approval new drugs and reduces corresponding costs.
Applications for the Project Consultation approach are assessed based on 4 indicators,
including “innovation,” “contribution,” “early achievement” and “regulatory compliance.” For
applications qualified to the above criteria, TFDA organizes a project team to provide consultation

43