Following the recent withdrawal of several branded drugs from the Taiwan market, Primary Pharmacist Association Chairperson Tsai-Ying Shen revealed that seven commonly used medications—including expectorants and lipid-lowering drugs—have already been pulled this year. Taiwan Food and Drug Administration (TFDA) Director-General Chih-Kang Chiang confirmed that a total of 47 pharmaceutical products are expected to be withdrawn from Taiwan in 2025. Of these, 46 have alternative options available, and one remaining product still has existing stock, ensuring that clinical treatment will not be affected. The TFDA has submitted a proposed amendment to the Pharmaceutical Affairs Act, requiring all companies to notify authorities at least six months in advance in the event of potential drug shortages.
Chiang explained that as of the end of September, the TFDA had identified 47 drugs slated for withdrawal from the market. Among them, 46 have alternative treatment options: 25 can be replaced by products with the same active ingredient, dosage, and formulation (“three-same drugs”), while 21 others have substitutes with either the same ingredient in different dosage forms, different ingredients with the same pharmacological mechanism, or different ingredients treating the same indications. Chiang added that physicians can also make flexible adjustments—for instance, prescribing alternative doses or increasing pill counts if high-dose products become unavailable—thereby preventing any disruption to clinical care.
The remaining product still in stock is a cyclosporine injectable immunosuppressant. The TFDA had previously issued a public request for special importation, and the original manufacturer has stated that supply will be available until the end of next year, so the withdrawal announcement has been temporarily postponed. Chiang emphasized that domestic manufacturers are already being engaged to produce substitute immunosuppressant products through special manufacturing arrangements, ensuring continuous supply.
Chiang noted that drug withdrawal decisions are not solely driven by pricing factors. Taiwan’s relatively small market size, along with cost, profit margins, and strategic adjustments by manufacturers, all play a role. However, most of these products are off-patent, and encouraging local production of generic alternatives is the key solution. Many countries worldwide are strengthening pharmaceutical supply chain resilience by promoting “localization of drug supply,” and Taiwan is following this approach by supporting domestic generic manufacturers to fill gaps when original drug makers exit the market.
To strengthen monitoring and response to potential shortages, the TFDA has proposed an amendment to the Pharmaceutical Affairs Act, now under review by the Executive Yuan. The revision stipulates that, beyond essential medicines managed by the central government, all pharmaceutical companies must notify authorities six months in advance if they foresee supply interruptions or market withdrawal. Chiang explained that under the current law, only drugs listed on the essential medicines list are subject to advance reporting requirements. The amendment expands this obligation to all drugs, ensuring that early warnings can be issued and proactive measures taken to safeguard public access to necessary medications.
Resource: 47項藥品退出台灣！姜至剛署長保證不影響臨床用藥 修法要求通報缺藥
