关键词:  , 穿透式监管；药品；医疗器械；监管效能

Abstract:

The Opinions on Comprehensively Deepening the Reform of Drug and Medical Device Regulation to Promote High-quality Development of the Pharmaceutical Industry， issued by the General Office of the State Council at the beginning of 2025， provides comprehensive planning and systematic deployment for further deepening reforms in drug regulation， explicitly proposing to strengthen regulatory informatization and explore the implementation of look-through supervision. Look-through supervision is not only an innovation and improvement of traditional regulatory models， but also a key measure to meet the demands of the new era of pharmaceutical industry development and ensure drug safety for the public. This study analyzes the connotations and characteristics of look-through supervision， explores its significance for drug regulatory work， discusses the main challenges faced in prompting look-through supervision， and proposes corresponding countermeasures and suggestions from the perspectives of regulatory philosophy， mechanisms， methods， technological tools， and regulatory team building. The aim is to provide theoretical support and practical guidance for accelerating the implementation of the State Council’s requirements on comprehensively deepening reforms in drug and medical device regulation and promoting high-quality development of the pharmaceutical industry， thereby effectively enhancing regulatory efficiency and ensuring drug safety for the public through look-through supervision.

Key words:  , Look-through supervision； , Drug； , Medical devices； , Regulatory efficiency