Page 132 - 2023 Taiwan Food and Drug Administration Annual Report
P. 132
2023 Taiwan Food and
Drug Administration
Annual Report
Date of Name Important content
announcement
Given that cell therapy medicinal products were
approved one after another around the world and
the development of cell therapy also grew quickly
November 7 The “Guidance on NDA for Cell Therapy Medicinal domestically, in order to meet the updated international
Products” was amended. management standards, TFDA amended this
guidance, describing the review considerations for cell
therapy medicinal products regarding manufacturing
and control, non-clinical, and clinical data.
This guidance provides appropriate standards for the
November 10 The “ICH Q5D: Guidance on Derivation and derivation, preparation, and characterization of cell
Characterization of Cell Substrates Used for lines, microbial cells from humans and animals and
Production of Biotechnological/Biological Products” cell banks to be used to prepare biotechnological/
was announced. biological products, with recommendations on the
information in these areas that should be presented in
marketing applications for such products.
Real-world Evidence (RWE) is the international
The “Guideline on Conducting Pharmacoepidemiologic clinical application trend. To promote the domestic
November 17 Safety Studies Using Electronic Healthcare Data” was drug R&D, FDA considered into the latest international
announced. management practices and stipulated relevant
guidelines as reference for the industry to follow.
This guidance and its FAQs were announced for
The “ICH E14: Guidance on The Clinical Evaluation the sake of establishing internationally harmonized
November 25 of QT/QTc Interval Prolongation and Proarrhythmic clinical trial management regulations of medicinal
Potential for Non-antiarrhythmic Drugs” and FAQs products and to be followed by the outside world on
were announced. safety update reports of medicinal products being
researched and developed.
In order to consolidate the drug relief application
procedure, the payment, and matters relevant
November 28 The “Regulations for Application and Deliberation to the organization of the Review Committee
of Drug Injury Relief” (Draft) was announced; the and the review performed, the draft amendment
“Regulations Governing Reviewing Procedure of Drug of “Regulations for Application and Deliberation
Injury Review Committee of Ministry of Health and of Drug Injury Relief” were prepared and the
Welfare” and the “Regulations for Drug Injury Relief “Regulations Governing Reviewing Procedure
Application” would be abolished. of Drug Injury Review Committee of Ministry of
Health and Welfare,” the “Regulations for Drug
Injury Relief Application,” and the “Drug Injury
Relief Payment Standard” were abolished.
The ICH released its ICH E18 guidance in
2017 to serve as the fundamental principles
December 6 The “ICH E18: Guideline on Genomic Sampling and for genomic sampling and genomic data
Management of Genomic Data” was announced. management relevant to clinical trials and
provided advice on sampling, storage, and proper
use to facilitate genomic studies.
To strengthen the mechanism for manufacturers
December 8 The draft amendment to the list of essential drugs in to announce in advance the insufficient supply of
Article 27-2 of the “Pharmaceutical Affairs Act” was essential drugs and to normalize the reporting and
announced. evaluation management system in case of shortage
in the supply of drugs, it was announced in advance
that the said List would be amended.
The “ICH E16: Guideline on Biomarkers Related to This guidance provides recommendations on
December 29 Drug or Biotechnology Product Development: Context, biomarker qualification for the development of drugs
Structure, and Format of Qualification Submissions” or biological products, and the submitted data shall be
was announced. complied with the CTD format.
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