Page 99 - 2023 Taiwan Health and Welfare Report

07 Management of Food and Drug 07

4. As part of the implementation of the "New Medicinal Plants" were promulgated. Subsequently,
Generation Anti-drug Strategy," a total of 24,669 on November 30, 2022, the application guidelines
batches were inspected by the end of 2022. for these measures were announced. The purpose
Among them, 2,280 batches underwent border of these measures is to incentivize the cultivation of
inspections using Portable Raman spectrometers medicinal plants and provide lease term protection
for active pharmaceutical ingredients (APIs), and for tenants engaging in the cultivation of medicinal
all results were in compliance with regulations. plants on public or state-owned land.
Simultaneously, a spectroscopic database was
4. Listed the trialed "Internship for Chinese Pharmacy
established, comprising 2,234 entries (including
Education," "Chinese Pharmacy Internship
APIs, illegal drugs and controlled drugs, etc.).
Instructor Training and Certification," and "Selection
Throughout the year, 100 standards of illegal
of locations for Chinese Pharmacy Internship
drugs and new substances were obtained, and
Locations," for the reference of colleges planning
a database of 102 standard mass spectrometry
Chinese pharmacy training courses.
charts were constructed. Additionally, active efforts
5. The fourth edition of the Taiwanese Pharmacopoeia
were made to develop recommended test methods.
came into effect on June 1, 2022. This edition
Section 6 Management of Chinese encompasses a total of 394 items, including 355
Medicine Chinese medicinal herbs, 30 Chinese medicinal
herb decoction pieces, and 9 Chinese medicinal
1. Starting from January 1, 2010, Chinese medicine
preparations. In the same year, the English
manufacturers of concentrated preparations have
version of the fourth edition of the Taiwanese
been implementing validation procedures in 4.
Pharmacopoeia was published in December.
In 2022, a total of 11 guidance was provided,
accompanied by 22 educational training sessions. 6. In 2022, a total of 21 Chinese medicine materials,
Three Chinese medicine manufacturers have including Ginseng and Angelica, underwent border
successfully passed the inspection for validation: inspections. A total of 2,585 batches (12,870
one manufacturer passed phases one to three, metric tons) were sampled and inspected, with
another passed phases one to two, and the third a cumulative sampling of 648 batches. Out of
manufacturer passed phase one. these batches, 14 batches were found to be
noncompliant and were appropriately returned or
2. From May 2021 to July 2022, a total of 13 licenses
for the export-exclusive medication "NRICM101" destroyed in accordance with the law. Furthermore,
were approved. These approvals were granted in quality monitoring was conducted on commercially
accordance with Article 48-2 of the Pharmaceutical available Chinese medicine products, with 410
Affairs Act and the "Regulations for the Approval samples being tested. Among them, 32 samples
of Specific Medicinal Products' Manufacturing or were found to be noncompliant and were dealt
Importing as a Special Case." Chinese medicine with according to legal procedures. In 2022, 167
manufacturers were permitted to carry out project violations in Chinese medicine advertisements were
manufacturing domestically, and the medication is investigated, resulting in administrative penalties on
categorized as "prescription for use by traditional amounting to a total fine of NTD 10,530,000.
Chinese medicine practitioners." As of the end 7. The "Traditional Chinese Medicine Herb Culture
of December 2022, it has been administered to Festival" Chinese medicinal herb culture event
1,444,206 confirmed COVID-19 patients. was organized to promote the knowledge and
3. On October 18, 2021, the "Regulations on Rewards culture of traditional Chinese medicine among the
and the Guarantee of Land Lease Period for the general public, with approximately 4,200 individuals
Lease of Public Lands or Lands owned by the participating in the physical event, and reaching
State-owned Enterprises to Cultivate Chinese 220,000 individuals via online engagement.

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