The Legislative Yuan passed amendments to the Pharmaceutical Affairs Act and the Drug Injury Relief Act in a third reading, aiming to strengthen early warning and response mechanisms for drug shortages and to prevent a recurrence of supply disruptions. The amendments shift the system from requiring manufacturers to notify authorities six months in advance of an anticipated supply shortage to a requirement that license holders of essential drugs regularly report their manufacturing, importation, and supply status, enabling regulators to monitor market conditions in a more timely manner.
To stabilize drug supply, the government had previously been limited to granting case-by-case approvals for the importation or manufacture of alternative medicines only when shortages involved “essential drugs.” As the list of essential drugs comprises only about 584 items, the amended law significantly expands the scope of such special approvals to cover all licensed medicines. In the event of drug shortages or major public health emergencies, the competent authority may also restrict the scope, duration, quantity, and eligible recipients of drug supplies to prevent excessive concentration at specific medical institutions and to improve public access to medicines.
The amendments also strengthen the drug injury relief framework. Going forward, medicines that are specially approved for manufacture or importation in response to drug shortages or public health emergencies such as pandemics will be covered under the Drug Injury Relief Act, providing more comprehensive protection for patients. In addition, companies that fail to comply with reporting requirements or cooperate with drug shortage management measures may be fined between NT$60,000 and NT$300,000 and ordered to rectify the violation within a prescribed period.
The Taiwan Food and Drug Administration stated that the amendments will strengthen authorities’ ability to monitor drug supply and better safeguard public interests. The pharmaceutical sector has largely welcomed the changes, but some have cautioned that the maximum fine of NT$300,000 may have limited deterrent effect. In practice, suppliers often prioritize deliveries to large hospitals with which they have contractual obligations, leaving clinics and community pharmacies to learn of shortages only at a late stage. The industry has therefore urged the competent authority to enforce the law rigorously and establish fair allocation mechanisms, giving frontline providers sufficient time to seek alternative medicines and preventing patients from being forced to return to large hospitals simply to fill prescriptions.
[2025-1-31/SET News]
