June 2026
Building a Safeguard for Pharmaceutical Supply Security – Taiwan Amends the Pharmaceutical Affairs Act and the Drug Injury Relief Act
On January 30, 2026, amendments to Certain Provisions of the Pharmaceutical Affairs Act and to Articles 3 and 28 of the Drug Injury Relief Act were passed by the Taiwan Legislative Yuan on third reading, and officially promulgated on March 4, 2026. The primary purpose of these amendments is to prevent a recurrence of the major saline solution supply disruption that occurred in 2024, when a leading intravenous infusion manufacturer was found to have seriously violated Good Manufacturing Practice (GMP) requirements and subsequently lost its pharmaceutical license upon expiration, resulting in a nationwide shortage of normal saline products.
To strengthen pharmaceutical supply resilience and prevent similar disruptions in the future, the amendments focus on three key areas: (1) monitoring the supply status of essential medicines, (2) enhancing measures to ensure a stable pharmaceutical supply, and (3) improving the drug injury relief system. These amendments carry significant implications for pharmaceutical companies' regular reporting obligations, the protection of patients' rights, and the maintenance of a stable drug supply. The key amendments are summarized below.
I. Strengthening Monitoring of the Supply of Essential Medicines
1. Previously, holders of licenses for medicines designated by the Ministry of Health and Welfare (“MOHW”) as essential medicines were only required to notify the MOHW before or after circumstances arose that might prevent the continued manufacture, importation, or adequate supply of such medicines. Under the amended law, a more comprehensive monitoring mechanism has been introduced. Pharmaceutical firms are now required to periodically report the manufacturing, importation, and supply status of essential medicines to the MOHW (Article 27-2 of the Pharmaceutical Affairs Act). Failure to submit required reports, submission of materially false reports, or repeated violations may result in administrative fines ranging from NT$60,000 to NT$300,000 (Article 96-1, Paragraph 2 of the Pharmaceutical Affairs Act).
2. To ensure balanced pharmaceutical supply across different regions, the amendments authorize the MOHW, in response to public health emergencies or events with significant public health impacts, to impose restrictions on the scope, duration, quantity, recipients, and methods of supply of pharmaceuticals holding specific licenses or pharmaceuticals specially approved for manufacture or importation (Article 27-3, Paragraph 2 of the Pharmaceutical Affairs Act). Pharmaceutical firms that violate such restrictions may be subject to administrative fines ranging from NT$60,000 to NT$300,000 and may be ordered to rectify the violation within a specified period. Failure to comply may result in consecutive penalties (Article 96-1, Paragraph 3 of the Pharmaceutical Affairs Act).
3. The amendments also expand the circumstances under which the MOHW may grant special approval for the manufacture or importation of specific pharmaceuticals. In addition to situations involving “urgent public health needs”, the law now expressly includes circumstances arising from “major public health impact events” (Article 48-2, Paragraph 1, Subparagraph 2 of the Pharmaceutical Affairs Act).
II. Enhancing the Drug Injury Relief System
To align with the amendments to the Pharmaceutical Affairs Act, the Drug Injury Relief Act now includes pharmaceuticals specially approved for manufacture or importation within the scope of lawful drugs eligible for relief. Accordingly, pharmaceuticals specially approved due to anticipated shortages of licensed drugs, or those approved in response to urgent public health needs or major public health impact events, are likewise covered under the drug injury relief system (Article 3 of the Drug Injury Relief Act).
To strengthen pharmaceutical supply resilience and prevent similar disruptions in the future, the amendments focus on three key areas: (1) monitoring the supply status of essential medicines, (2) enhancing measures to ensure a stable pharmaceutical supply, and (3) improving the drug injury relief system. These amendments carry significant implications for pharmaceutical companies' regular reporting obligations, the protection of patients' rights, and the maintenance of a stable drug supply. The key amendments are summarized below.
I. Strengthening Monitoring of the Supply of Essential Medicines
1. Previously, holders of licenses for medicines designated by the Ministry of Health and Welfare (“MOHW”) as essential medicines were only required to notify the MOHW before or after circumstances arose that might prevent the continued manufacture, importation, or adequate supply of such medicines. Under the amended law, a more comprehensive monitoring mechanism has been introduced. Pharmaceutical firms are now required to periodically report the manufacturing, importation, and supply status of essential medicines to the MOHW (Article 27-2 of the Pharmaceutical Affairs Act). Failure to submit required reports, submission of materially false reports, or repeated violations may result in administrative fines ranging from NT$60,000 to NT$300,000 (Article 96-1, Paragraph 2 of the Pharmaceutical Affairs Act).
2. To ensure balanced pharmaceutical supply across different regions, the amendments authorize the MOHW, in response to public health emergencies or events with significant public health impacts, to impose restrictions on the scope, duration, quantity, recipients, and methods of supply of pharmaceuticals holding specific licenses or pharmaceuticals specially approved for manufacture or importation (Article 27-3, Paragraph 2 of the Pharmaceutical Affairs Act). Pharmaceutical firms that violate such restrictions may be subject to administrative fines ranging from NT$60,000 to NT$300,000 and may be ordered to rectify the violation within a specified period. Failure to comply may result in consecutive penalties (Article 96-1, Paragraph 3 of the Pharmaceutical Affairs Act).
3. The amendments also expand the circumstances under which the MOHW may grant special approval for the manufacture or importation of specific pharmaceuticals. In addition to situations involving “urgent public health needs”, the law now expressly includes circumstances arising from “major public health impact events” (Article 48-2, Paragraph 1, Subparagraph 2 of the Pharmaceutical Affairs Act).
II. Enhancing the Drug Injury Relief System
To align with the amendments to the Pharmaceutical Affairs Act, the Drug Injury Relief Act now includes pharmaceuticals specially approved for manufacture or importation within the scope of lawful drugs eligible for relief. Accordingly, pharmaceuticals specially approved due to anticipated shortages of licensed drugs, or those approved in response to urgent public health needs or major public health impact events, are likewise covered under the drug injury relief system (Article 3 of the Drug Injury Relief Act).
