Page 45 - 2023 Taiwan Food and Drug Administration Annual Report

3Advancement of Drug
of medicinal products ensured and under the
condition that the review criteria are consistent the Executive Yuan, the Act will be sent
for all new chemical entities, the original 2013
announcement amended to include domestic
new chemical entities (excluding biological
medicinal products) that have been approved
for market for over 5 years in A10 countries,
with quality, safety, and efficacy having been
approved by the regulatory authorities and
consumer reception available that may be used
to support the review.
III. Implementation of linkage
to patents of Drugs
The Drug linkage system was enforced
on August 20, 2019. The registration system
for patent linkage of drugs was created
in compliance with Article 48-8 of the
“Pharmaceutical Affairs Act”. The new drug
owner registered patent information provided
and released, it perfects the intellectual
property protection setting for medicinal
products in our country and boosts the
willingness of developers to invest in the R&D
of new drugs in Taiwan.
▍ Achievements and Benefits
I. Improving the regulations
for regenerative medicinal
products
The “Regenerative Medicinal Products
Act (draft)” was submitted to the Executive
Yuan for review on May 3 and September
Management
22, 2022; once reviewed and approved by
to the Legislative Yuan for examination.
The “Guidance on NDA for Gene Therapy
Medicinal Products” was announced on July
1, 2022. Besides, the revised “Guidance on
NDA for Cell Therapy Medicinal Products”
was announced on November 7, 2022, in order
to improve the regulatory environment for
regenerative medicinal products.
II. Increased accessibility of
new drugs
For medicinal products already approved
for market overseas subsequently applying
for registration in Taiwan, under the premise
that patents of medicinal products owned by
others are not infringed upon, the released data
and patient reception of the specific medicinal
product may be reasonably used to support
part of the reference materials required for
the review of the quality safety, and efficacy
of the medicinal product. It was announced
on September 30, 2022, that the NCE-2
requirements were amended; new chemical
entities that have been approved for marketing
for over 5 years in A10 countries apply,
allowing for early introduction of a medicinal
product to the market, helping to increase the
accessibility of new drugs.
III. Strengthening of the
transparency of the patent
linkage system
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