In light of recent challenges to the stability of pharmaceutical supply—arising from emerging infectious diseases, geopolitical risks, and global supply chain disruptions—the Legislative Yuan, on January 30, 2026, passed the third reading of partial amendments of the Pharmaceutical Affairs Act and the Drug Injury Relief Act. These amendments aim to enhance oversight of essential drug supply, strengthen measures to ensure drug supply stability, and safeguard the public’s right to access medications and protect public health. The key amendments are summarized as follows:

1. Transition from “anticipated reporting” to “periodic reporting”: A new requirement mandates that pharmaceutical firms holding license for essential drugs must periodically report to the central competent health authority on the manufacturing, importation, and supply status of such drugs. This includes current inventory levels, past monthly shipment volumes, and future plans for manufacturing, importation, and supply (Pharmaceutical Affairs Act, Article 27-2, Paragraph 1). If a drug license holder fails to report as required or submits false information, the central competent health authority may publicly disclose the name of the firm, address, name of the responsible person, name of the drug, and violation detail. In cases of serious violations or repeated violation, fines ranging from NT$60,000 to NT$300,000 may be imposed (Pharmaceutical Affairs Act, Article 96-1, Paragraph 2).

2. Expansion of emergency drug special approval’s scope and allocation authority from “essential drugs” to “all drugs that hold a license”: The amendments authorize the central competent health authority, in response to emergencies or events significantly affecting public health, to impose restrictions on the scope, duration, quantity, target recipients, or methods of supply for drugs that have obtained a license or have been approved as a special case for manufacture or import. These measures aim to prevent and respond to public health emergencies, reduce concerns among pharmaceutical firms, and encourage them to undertake manufacturing or importation of specially approved drugs for the public welfare when supply shortages are anticipated. The amendments also enable the authority to ensure balanced regional distribution of pharmaceuticals and maintain accessibility for the public, thereby protecting the public’s health rights (Pharmaceutical Affairs Act, Article 27-3, Paragraph 2). Pharmaceutical firms that violate such restriction measures may be fined between NT$60,000 and NT$300,000 and ordered to rectify within a specified period; failure to comply may result in consecutive penalties (Pharmaceutical Affairs Act, Article 96-1, Paragraph 3). Notably, the legislative reasoning for Article 27-3 of the Pharmaceutical Affairs Act clarifies that if a pharmaceutical firm is unable to fulfill its contractual supply obligations due to compliance with such government-imposed restrictions, such non-performance is attributable to legal requirements or lawful administrative actions by the competent authority, and such non-performance is generally not attributable to the firm. Accordingly, liability shall be determined in accordance with relevant provisions of the Civil Code.

3. Enhancement of the drug injury relief system: In coordination with the amendments to the Pharmaceutical Affairs Act, drugs that are approved as special cases for manufacture or import under Article 27-3, Paragraph 1, and Article 48-2, Paragraph 1, Subparagraph 2 of the same Act are now included within the scope of the drug injury relief system. This expansion addresses widespread medical needs and ensures that individuals who suffer drug-related injuries from such products may obtain timely relief under the law (Drug Injury Relief Act, Article 3, Paragraph 1, Subparagraph 2).Enhancement of the drug injury relief system: In coordination with the amendments to the Pharmaceutical Affairs Act, drugs that are approved as special cases for manufacture or import under Article 27-3, Paragraph 1, and Article 48-2, Paragraph 1, Subparagraph 2 of the same Act are now included within the scope of the drug injury relief system. This expansion addresses widespread medical needs and ensures that individuals who suffer drug-related injuries from such products may obtain timely relief under the law (Drug Injury Relief Act, Article 3, Paragraph 1, Subparagraph 2).

Following the promulgation and implementation of the above provisions, pharmaceutical firms should pay close attention to the new reporting obligations and comply with restriction measures imposed by the competent authority to avoid penalties.

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References:

1. Legislative Yuan, 11th Term, 4th Session, 20th Meeting—Agenda Related Documents.

2. Legislative Yuan passes third reading on the passage of “Draft Amendments to Certain Provisions of the Pharmaceutical Affairs Act” and “Draft Amendments to Articles 3 and 28 of the Drug Injury Relief Act”, aimed at enhancing the resilience of Taiwan’s pharmaceutical supply,

https://www.fda.gov.tw/TC/newsContent.aspx?cid=4&id=t624074.

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