Self-paid Anti-Influenza Drug Shufuxiao Once Short, Failure to Report in Advance Fined NT$60,000
Taiwan's Food and Drug Administration (FDA) fined Shionogi Pharmaceutical NT$60,000 for failing to report in advance the shortage of the self-paid anti-influenza drug "Shufuxiao Film-Coated Tablets 20mg," a necessary medicine. The drug's supply has normalized since February 5, 115 (2026).
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- 📰 Published: May 8, 2026 at 19:09
- 🔍 Collected: May 8, 2026 at 19:32 (22 min after Published)
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Central News Agency
(Central News Agency reporter Shen Pei-yao, Taipei, 8th) The Food and Drug Administration (FDA) recently announced that Shionogi Pharmaceutical, the license holder for "Shufuxiao Film-Coated Tablets 20mg," a self-paid anti-influenza drug and one of the necessary medicines, failed to report the drug shortage in advance as required by the Pharmaceutical Affairs Act, resulting in a fine of NT$60,000 and the public disclosure of the pharmaceutical company's name, address, and responsible person's name.
The Ministry of Health and Welfare's Food and Drug Administration previously announced that Taiwan Shionogi Pharmaceutical Co., Ltd., which imported "Shufuxiao Film-Coated Tablets 20mg" (Ministry of Health and Welfare Drug Import Permit No. 027693), failed to report within the time limit stipulated by the Pharmaceutical Affairs Act.
FDA Senior Technical Specialist Huang Mei-chen told the Central News Agency today that "Shufuxiao Film-Coated Tablets 20mg" (Ministry of Health and Welfare Drug Import Permit No. 027693) has "Baloxavir" as its main ingredient and is a necessary medicine announced under the Pharmaceutical Affairs Act.
Huang Mei-chen said that Taiwan Shionogi Pharmaceutical Co., Ltd., as the holder of the drug license, reported on September 26, 114 (2025), that the supply of this product would be affected from the end of September 114 (2025) due to production capacity issues at the original manufacturer.
The FDA therefore followed procedures and asked Shionogi Pharmaceutical to explain whether it complied with the reporting deadline requirements of the Pharmaceutical Affairs Act. Huang Mei-chen stated that based on the company's reply, it was determined that the company failed to report within the time limit stipulated by the Pharmaceutical Affairs Act, and a fine of NT$60,000 was imposed according to law, with the pharmaceutical company's name, address, responsible person's name, drug name, and violation details publicly disclosed on the FDA's Western Medicine and Medical Device Supply Information Platform.
Huang Mei-chen stated that considering there are no alternative drugs with the same ingredient, dosage form, and dosage in Taiwan, and compared to alternative drugs with different ingredients, this drug has not shown any drug resistance-related mutations, the FDA, considering clinical needs, approved emergency imports on November 5, 114 (2025), to bridge the supply gap.
In addition, the drug's supply has normalized since February 5, 115 (2026), and has been announced on the Western Medicine and Medical Device Supply Information Platform. (Editor: Hsieh Ya-chu) 1150508
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(Central News Agency reporter Shen Pei-yao, Taipei, 8th) The Food and Drug Administration (FDA) recently announced that Shionogi Pharmaceutical, the license holder for "Shufuxiao Film-Coated Tablets 20mg," a self-paid anti-influenza drug and one of the necessary medicines, failed to report the drug shortage in advance as required by the Pharmaceutical Affairs Act, resulting in a fine of NT$60,000 and the public disclosure of the pharmaceutical company's name, address, and responsible person's name.
The Ministry of Health and Welfare's Food and Drug Administration previously announced that Taiwan Shionogi Pharmaceutical Co., Ltd., which imported "Shufuxiao Film-Coated Tablets 20mg" (Ministry of Health and Welfare Drug Import Permit No. 027693), failed to report within the time limit stipulated by the Pharmaceutical Affairs Act.
FDA Senior Technical Specialist Huang Mei-chen told the Central News Agency today that "Shufuxiao Film-Coated Tablets 20mg" (Ministry of Health and Welfare Drug Import Permit No. 027693) has "Baloxavir" as its main ingredient and is a necessary medicine announced under the Pharmaceutical Affairs Act.
Huang Mei-chen said that Taiwan Shionogi Pharmaceutical Co., Ltd., as the holder of the drug license, reported on September 26, 114 (2025), that the supply of this product would be affected from the end of September 114 (2025) due to production capacity issues at the original manufacturer.
The FDA therefore followed procedures and asked Shionogi Pharmaceutical to explain whether it complied with the reporting deadline requirements of the Pharmaceutical Affairs Act. Huang Mei-chen stated that based on the company's reply, it was determined that the company failed to report within the time limit stipulated by the Pharmaceutical Affairs Act, and a fine of NT$60,000 was imposed according to law, with the pharmaceutical company's name, address, responsible person's name, drug name, and violation details publicly disclosed on the FDA's Western Medicine and Medical Device Supply Information Platform.
Huang Mei-chen stated that considering there are no alternative drugs with the same ingredient, dosage form, and dosage in Taiwan, and compared to alternative drugs with different ingredients, this drug has not shown any drug resistance-related mutations, the FDA, considering clinical needs, approved emergency imports on November 5, 114 (2025), to bridge the supply gap.
In addition, the drug's supply has normalized since February 5, 115 (2026), and has been announced on the Western Medicine and Medical Device Supply Information Platform. (Editor: Hsieh Ya-chu) 1150508
Choose to stand with facts, every sponsorship you make is a force to protect press freedom.
Download the Central News Agency "First-hand News" APP to get the latest news instantly.
The text, images, and audio-visual content of this website may not be reproduced, publicly broadcast, publicly transmitted, or utilized without authorization.