Page 42 - 2020Taiwan Food and Drug Administration Annual Report

“Accelerated Approval Mechanism for New Drug Applications,” and “Points to Consider for
Breakthrough Therapy Designation.” The purpose is to encourage the development and reach
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comparing with the existing treatment, by utilizing approaches such as providing regulatory
consultation and technical issue consultations during new drug developments.

II. Amendment to the standards and regulations of non-prescription drugs
To comply with the international trend of non-prescription drugs, and to promote the
development of pharmaceutical industries in Taiwan, with reference to the drug managements in
Europe, USA, Japan, and Australia, as well as taking into account the domestic pharmaceutical

market, TFDA continues to review the standards and regulations of non-prescription drugs,
expend the list of non-prescription drugs, implement the professional role of pharmacists, and
increase the usage of non-prescription drugs.

III. Stipulated the patent linkage system of drugs
By referencing regulations of the US, Canada, and South Korea and the current status
of the pharmaceutical industry development in Taiwan, TFDA added Chapter 4-1 “Patent
linkage of Drugs” in the Pharmaceutical Affairs Act and it was announced for implementation
on August 20, 2019. The drug permit holder deems it necessary to submit patent information
regarding substance, composition or formulation and medical use within the statutory limitation.
The application of generic drug market approval is required to provide the patent status of the
approved new drug. The applicant for a generic drug market approval must inform the license

holder, patent owner and exclusive authorized person of the novel drug in advance. Thus to
allow the person of interest to validate the patent or the potential patent infringement. The
central competent health authorities may continue reviewing the application of the generic drug
application. However, the market approval of a drug may be temporarily suspended under special
circumstances within 12 months. A 12-month exclusive period for market sales will be given
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infringement.

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I. Facilitation on New Drug Approvals

With the core objectives of quality, consistency, clarity, efficiency, and transparency in
review of drugs, and with the expectation to reach early access of new drugs, TFDA reinforce
the two-way communication between the regulators and industries, promoting regulatory
harmonization, improving drug review and management system. Among the 100 new drugs
approved in 2019, 37 are new drugs with new chemical entities and 22 are biological products.

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