Research on quality management, responsibilities and regulatory measures of the domestic responsible person for drugs

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Affiliation: Shanghai Center for Adverse Drug and Medical Device Reaction Monitoring, Shanghai 200031, China

Keywords: Imported drugs Domestic responsible entity Overseas marketing authorization holders Quality management responsibility Responsible entity Obligation Challenge Supervision

DOI: 10.12173/j.issn.2097-4922.202510051

Reference: WANG Ying, WANG Guangping. Research on quality management, responsibilities and regulatory measures of the domestic responsible person for drugs[J]. Yaoxue QianYan Zazhi, 2025, 29(12): 2088-2097. DOI: 10.12173/j.issn.2097-4922.202510051.[Article in Chinese]  Copied

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Abstract

Objective Under the background of the implementation of the Tentative Provisions for the Administration of the Designation of a Domestic Responsible Person by Foreign Marketing Authorization Holders, to promote the optimization and improvement of the domestic responsible persons for drugs.

Methods Through document and literature review, on-site investigation, expert consultation, and other methods, the legal obligations and responsibility delineation of domestic drug responsible persons at home and abroad were understood, the job responsibilities of domestic responsible persons in China were systematically sorted out, and the regulatory challenges faced by domestic responsible persons in the process of responsibility implementation were analyzed.

Results The system design of the domestic responsible person had formed a dual-subject responsibility system of "overseas holder+domestic responsible person", and had established a segmented management model where the registration management of imported drugs was handled by the state and the circulation management by local authorities, filling the previous regulatory gap of ambiguous responsible subjects for drugs produced abroad in China. It had also brought about new regulatory challenges, including difficulties in cross-border liability traceability, inconsistent regulatory standards, insufficient cross-regional collaborative regulatory mechanisms, and the need to enhance technical support capabilities.

Conclusion By implementing suggestions to improve the legal system, establishing cross-regional collaboration mechanisms, empowering supervision with technology, and promoting market-oriented risk-sharing tools, the regulatory efficiency of domestic responsible persons can be enhanced to ensure the quality and safety of imported drugs.

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