The Trump administration in the United States plans to increase tariffs on pharmaceutical products. In response, the Ministry of Health and Welfare (MOHW) has activated corresponding measures, including strengthening the alert system, increasing drug price flexibility, and more. The MOHW is also working to accelerate the drug review process, allowing drug licenses to be obtained in as little as 120 days, compared to the standard 360 days. All these measures aim to maintain the resilience of Taiwan's drug supply.
Dr. Wang Der-Yuang, Deputy Director of the Taiwan Food and Drug Administration (TFDA), stated that in order to reduce reliance on a single source of active pharmaceutical ingredients (APIs), the MOHW continues to encourage pharmaceutical companies to diversify their API sources and maintain a safety stock. The authority will also assist businesses in obtaining drug licenses more quickly.
Dr. Wang noted that under the current “Optimized Review Measures for New Drug Registration and Evaluation,” it typically takes 360 days to complete the review process for new chemical entity (NCE) drugs or new biologics. However, an accelerated pathway, which takes 240 days, is available for treatments for pediatric patients, drugs for rare diseases, breakthrough therapies, or drugs designated for accelerated review.
For NCE drugs or new biologics that have already obtained two drug licenses from the United States, EU countries, or Japan, they may qualify for the 180-day Category 1 Simplified Review or the 120-day Category 2 Simplified Review—provided that the same CMC (Chemistry, Manufacturing, and Controls) data is submitted.
Regarding the diversification of API supply sources, Dr. Wang noted that most APIs are currently imported from China and India. The authorities have asked pharmaceutical companies to evaluate the possibility of expanding their supply sources. The TFDA will prioritize the review of APIs that currently come from a single source. Dr. Wang also pointed out that Taiwan has the capacity to manufacture APIs; however, drug manufacturers often prefer imported APIs due to cost concerns. The government will encourage manufacturers to give priority to locally produced APIs.
Also, the TFDA has completed its review of drugs imported from the United States and has requested pharmaceutical companies to closely monitor the supply situation and stock levels in Taiwan—especially for essential drugs such as orphan drugs, cancer treatments, and biologics. If there are concerns about potential shortages, the TFDA will investigate the situation and take appropriate countermeasures.
Regarding drug prices, the TFDA has compiled a list of drugs at risk due to the ongoing tariff war. Pharmaceutical companies may request price adjustments if manufacturing costs increase as a result of changes in the global supply chain. The TFDA will also continue to promote the use of generic drugs and biosimilars, as well as support the production of drugs made in Taiwan.
【2025-04-21 / Central News Agency】
