Regulatory framework and challenges for live biotherapeutic products in Taiwan

Shirley Pan^a,1, Jia-Chuan Hsu^a, Kuo-Teng Hung^a, Ching-Jung Ho^a

^a Taiwan Food and Drug Administration, Ministry of Health and Welfare, Taipei, Taiwan

Products containing live microorganisms may be classified as food or drugs depending on their intended use; live biotherapeutic products (LBPs) with therapeutic claims are defined as medicinal products containing live bacteria or yeasts intended to prevent or treat disease. Based on their characteristics, LBPs are classified as biological drugs and must be registered as biological drugs before they can enter the Taiwanese market. As research into the microbiota and its role in health and disease continues to advance, LBPs are expected to play an increasingly important role in medicine and biotechnology. With the growing popularity of microbial applications in recent years, there is still a lack of awareness regarding the management and regulation of such products. This article outlines the development, manufacturing, and marketing requirements of LBPs in Taiwan. After searching relevant literature, we summarized the regulations or related guidelines on LBPs from regulatory agencies such as the U.S. FDA, EMA, PMDA, and ICH. And compare the current requirements for LBPs in Taiwan. Key regulatory aspects of LBPs in Taiwan include definitions and classifications, quality and manufacturing requirements, clinical evidence, labeling and packaging information, post-marketing surveillance, etc. Regulations of LBPs in Taiwan align with international standards, but Taiwan authorities must be more inclusive in addressing new challenges facing LBPs innovation. This highlights the importance of continuous regulatory adaptation to foster innovation while ensuring safety and efficacy. Collaboration between regulatory bodies, industry stakeholders, and scientific communities will be essential to promoting innovation while maintaining robust regulatory oversight in the LBPs sector. In summary, while LBPs have significant therapeutic potential, addressing the regulatory challenges associated with their development, approval, and post-marketing surveillance is critical to ensure their safety, efficacy, and successful integration into clinical practice.