Abstract:
OBJECTIVE To review the current policies, regulations, and guidances governing Narrow Therapeutic Index Drugs(NTIDs) in China, and by drawing on international best practices, to provide policy recommendations aimed at ensuring the safe use of NTIDs in China.
METHODS Adopting a whole-life cycle management perspective with a focus on medication safety, the study carried out a comprehensive analysis of NTIDs-related policies and guidances from typical countries(regions). The analysis covered four critical areas of NTIDs regulation: definition and identification, development and registration, clinical use, and post-market surveillance.
RESULTS While China had introduced relevant policies and technical guidelines for NTIDs quality control and bioequivalence evaluation, significant gaps remained in the clear identification of NTIDs categories, the regulation of clinical substitution, and the establishment of robust post-market surveillance mechanisms. In contrast, countries(regions) such as the United States and the European Union had established preliminary whole-life cycle regulatory frameworks, offering valuable insights for optimizing China’s NTIDs policies.
CONCLUSION It is recommended to build a comprehensive NTIDs whole-life cycle management system in China. Key strategies include promoting multi-stakeholder collaboration in lifecycle governance, continuously updating bioequivalence guidelines by regulatory authorities, managing the risks associated with generic substitution in volume-based procurement, and standardizing post-market safety monitoring mechanisms for NTIDs to enhance medication safety.
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