On May 2025, Taiwan’s Ministry of Health and Welfare (MOHW) announced a significant regulatory update for cell therapy. Starting in 2028, all cell therapy applications—including new submissions, amendments, and extensions—must include documented proof of reagent quality along with viral inactivation or clearance validation data. Applications failing to meet these criteria will not be approved. The announcement clearly states that any reagent derived from human or animal sources must be accompanied by risk assessments for potential pathogens and evidence of effective viral inactivation or control measures.

Industry Solution: BioLife’s Virus-Reduced hPL Products – nLiven and TLiven

In response to this regulatory shift, PurpleWin Industrial Co., Ltd. strongly recommends BioLife's virus-reduced human platelet lysate (hPL) products, nLiven and TLiven, developed in the United States. These products utilize proprietary E-beam (electron beam) irradiation technology, offering highly effective pathogen inactivation with deep penetration and low-temperature processing, ensuring protein stability and functionality.

nLiven and TLiven come with comprehensive supporting documentation, including an active Drug Master File (DMF) with the FDA and PMDA applicability documentation in Japan. These products are suitable for clinical use in Taiwan, the U.S., EU, and other regulated markets. With full traceability, quality certification, and virus inactivation performance data, BioLife has become the preferred partner for cell therapy developers navigating evolving compliance requirements.

For more information or technical support, please contact PurpleWin Industrial at +886-2-7720-1566.