The newly finalized U.S.–Taiwan trade agreement includes Taiwan’s commitment to expedite the review of advanced U.S.-manufactured pharmaceuticals and medical devices. The International Research-Based Pharmaceutical Manufacturers Association (IRPMA) welcomed the move as a major breakthrough in bilateral pharmaceutical and medical device cooperation, noting that it will promote industrial upgrading, enhance healthcare system efficiency, and strengthen supply resilience.

Under the agreement, products that have obtained approval from the U.S. Food and Drug Administration (FDA) may serve as substantial supporting evidence when applying for marketing authorization in Taiwan. This mechanism is expected to streamline previously lengthy review procedures, while remaining subject to rigorous regulatory oversight by Taiwan’s FDA, thereby enabling faster patient access to safe, high-quality medicines and medical devices.

The agreement further highlights greater transparency, fairness, and predictability in National Health Insurance (NHI) reimbursement and listing processes, along with improved accessibility of drug information. According to IRPMA, this milestone not only enhances patient access to innovative therapies but also reinforces the U.S.–Taiwan strategic partnership and demonstrates Taiwan’s commitment to patient-centered care aligned with international best practices.

【2025-02-14/ETtoday】