Page 130 - 2023 Taiwan Food and Drug Administration Annual Report
P. 130
2023 Taiwan Food and
Drug Administration
Annual Report
▍ Exhibit 5 Additions and revisions to laws, regulations, and standards on drug
management in 2022
Date of Name Important content
announcement
The Draft Act was established to provide early
January 13 access to regenerative medicinal products for the
The “Regenerative Medicinal Products Act” (Draft) was general public and to boost the development of the
announced. regenerative medicine industry, aiming to provide
well-established management for regenerative
medicinal products.
January 27 The “ICH Q6B: Guidance on Specifications: Test The guidance establishes general principles for
Procedures and Acceptance Criteria for Biotechnological/ proteins and polypeptide products that are produced
Biological Products” was announced. from recombinant or non-recombinant cell-culture
expression systems.
The list aims to assist the pharmaceutical
February 24 The updated version of “The list of ICH guidelines industry to follow and for reference, describe ICH
April 15
April 21 adopted” was announced. guidelines key points, scope of applications and the
July 1
July 20 corresponding reference materials in Taiwan.
July 27
To p e r f e c t t h e p h a r m a c o v i g i l a n c e s y s t e m
in our country, the scope of application of
pharmacovigilance, the duration of data storage
The “Regulations for the Management of Drug Safety and data transfer, the Pharmacovigilance Plan,
Surveillance” was amended. the format of the report prepared, and drug safety
inspections, among other applicable requirements
were amended, and added in an effort to
consolidate the pharmacovigilance system in our
country.
The guidance provides suggestions on the
The “ICH Q5B: Guidance on Quality of Biotechnological characterization of the expression construct for the
Products: Analysis of the Expression Construct in Cells production of recombinant DNA protein products
Used for Production of r-DNA Derived Protein Products” in eukaryotic and prokaryotic cells and assessing
was announced. the structure of the expression construct used to
produce recombinant DNA derived proteins.
In response to the international trend in the
development of regenerative medicinal products,
TFDA established this guidance with reference to
The “Guidance on NDA for Gene Therapy Medicinal international standards and described the review
Products” was announced. considerations for gene therapy medicinal products,
providing the basis for the industry during research
and development and promoting the development
of gene therapy medicinal products in Taiwan.
For the sake of advancing the domestic
pharmaceutical service quality and to connect with
The “Regulations on Good Practices for Drug the world, international regulations were referenced
Dispensation” were amended. and the current pharmacy status in our country was
taken into consideration while the Regulations were
amended for perfecting the dispensing process for
medicinal products.
Requirements over materials to be enclosed in
the application for approval of specific medicinal
products, additional provisions that may be added
The “Regulations for Approval of Specific Medicinal upon approval, disclosure of information, effective
Products' Manufacturing or Importing as a Special Case” period, and matters that shall be reported and
was amended. documented following an extension, change,
and approval. It will be considered as a safety or
medical efficacy concern if the additional provisions
or the expected items are not enforced.
128
