Page 131 - 2023 Taiwan Food and Drug Administration Annual Report

7Appendix

Date of Name Important content
announcement

This guidance includes the criteria for submitting

reports on medicinal products researched and

developed (including further studies of medicinal

August 31 The “ICH E2F: Guideline on Development Safety Update products already available on the market)

Report” was announced. periodically and the recommended contents and

formats of the DSUR as well as an overview of

important points to be considered while preparing

and submitting the report.

September 2 In light of the fact that the Regulations had not
been amended for more than 18 years since they
were first released and enforced and that current
articles and contents no longer reflect applicable
The “Regulations for Reporting Severe Adverse international requirements about reporting, it
Reactions of Medicaments” (Draft) was announced. was intended to better applicable regulations.
Highlights of the amendment include modified
reporting methods, contents, and duration; and
pharmaceutical dealers are asked to investigate,
evaluate, and follow up on reported cases.

September 30 The “Key Points of Review for new chemical entities The amendments aim to ensure the quality,
(excluding biological medicinal products) that have safety, and efficacy of medicinal products, as
been approved for market in A10 countries for over 5 well as the consistency of review standards
years” was amended. for all new chemical entities, and promote the
accessibility of new drugs.

In light of the importance of including sex

differences as part of the considerations for

October 12 The “Guidance on Considerations for Analysis of Sex clinical trials of medicinal products, this guidance
Differences in Clinical Trials” was announced. was announced and provided to the medicine
community and academic research units for their

reference. This guidance is the first clinical trial

guide promoting sexual and health equality.

To go with the limits, analysis method, and heavy

metal testing indicated in General Provisions:

Element Impurities of Chinese Pharmacopeia of

October 24 The “Guidance on The Q3D implementation procedure the 9th edition and with reference to how they are
for the control of elemental impurities” was announced. implemented in the European Union, the United
States, and Japan, the implementation schedule

and method for the control of element impurities

in medicinal products in our country were defined

and announced.

In order to keep illicit drugs out of the legitimate

November 2 The draft amendment to the drug categories in supply chain, TFDA continued to analyze data of NHI-
the trace and track system in Article 6-1 of the covered drugs that have been declared and modify
“Pharmaceutical Affairs Act” was announced. drug items of high interest on a rolling basis in order to
protect medication safety. This is why the amendment

was announced in advance.

For enhanced administrative efficiency and to

keep the process flexible, Article 19-1 was added

to the Regulations. It specifies that, if necessary,

November 3 Article 19-1 of the “Regulations on Management of the central competent health authority may

Medicament Samples and Gifts” was amended. delegate all or part of the review of drug samples

or gifts applied to any of its subordinate agency

or commission to any other related agency

(institution), legal entity, or organization.

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