Page 101 - 2024 Taiwan Health and Welfare Report

07 ｜ Management of Food and Drug

4. As part of the implementation of the "New 5. The fourth edition of the Taiwanese Pharmacopoeia
Generation Anti-drug Strategy," a total of 30,120 came into effect on June 1, 2022. This edition
batches were inspected by the end of 2023. encompasses a total of 394 items, including 355
Among them, 2,367 batches underwent border Chinese medicinal herbs, 30 Chinese medicinal
inspections using Portable Raman spectrometers herb decoction pieces, and 9 Chinese medicinal
for active pharmaceutical ingredients (APIs), and preparations. In the same year, the English
all results were in compliance with regulations. version of the fourth edition of the Taiwanese
Simultaneously, a spectroscopic database was Pharmacopoeia was published in December.
established, comprising 2,337 entries (including 6. In 2023, a total of 21 Chinese medicine materials,
APIs, illegal drugs and controlled drugs, etc.). including Ginseng and Angelica, underwent border
Throughout the year, 100 standards of illegal inspections. A total of 2,885 batches (11,629
drugs and new substances were obtained, and metric tons) were sampled and inspected, with
a database of 123 standard mass spectrometry a cumulative sampling of 1,180 batches. Out
charts were constructed. Additionally, active efforts of these batches, 22 batches were found to be
were made to develop recommended test methods. noncompliant and were appropriately returned or
destroyed in accordance with the law. Furthermore,
Section 6 Management of Chinese
quality monitoring was conducted on commercially
Medicine
available Chinese medicine products, with 742
1. Starting from January 1, 2020, the manufacture of samples being tested. Among them, 47 samples
concentrated herbal medicine products by Chinese were found to be noncompliant and were dealt
herbal medicine manufacturers was implemented with according to legal procedures. In 2023, 239
validation procedures in four phases. In 2023, 8 violations in Chinese medicine advertisements were
manufacturers were guided, and a 12-hour training investigated, resulting in administrative penalties on
program was conducted. Eight Chinese herbal amounting to a total fine of NTD 15,535,000.
medicine manufacturers have passed the verification 7. The "Traditional Chinese Medicine Herb Culture
inspections (1 passed Phase 3, 4 passed Phase 2, Festival" Chinese medicinal herb culture event
and 3 passed Phase 1).
was organized in 2023 to promote the knowledge
2. On April 27, 2023, amendments to certain and culture of traditional Chinese medicine among
provisions of the "Regulations for Registration of the general public, with approximately 31,600
Medicinal Products" were announced to deregulate individuals participating in the physical event, and
and facilitate the development of the Chinese herbal reaching 100,000 individuals via online engagement.
medicine industry and new drugs.
3. On August 1, 2023, amendments to the "The Chapter 3 Management of Medical
Standards of Clinical Trials for TCM-based New Devices and Cosmetics
Drugs" were announced to establish an appropriate To effectively control the safety and quality of
clinical trial environment for Chinese herbal medical devices and cosmetics, a comprehensive
medicines and promote the development of new quality management policy was drafted, covering
Chinese herbal medicines. various aspects, including international regulatory
4. In 2023, subsidies were provided for the "Chinese harmonization, tracking management, pre-market
Herbal Medicinal Plant Cultivation Program" to inspections, post-market surveillance and supply chain
support 4 subsidized organizations in cultivating management.
Strobilanthes cusia, Pueraria montana, and
Dendrobium nobile, promoting self-sufficiency
in Chinese herbal materials and reducing import
reliance.

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