T/SHSPTA 009-2025 Directive for quality management of designated domestic responsible persons by overseas drug marketing authorization holders

Scope

This document stipulates the responsibilities of overseas drug marketing authorization holders (hereinafter referred to as "overseas holders"), the conditions and requirements for domestic responsible persons, reporting and changes by domestic responsible persons, the quality assurance system of domestic responsible persons, drug traceability, post-marketing changes and re-registration of drugs, pharmacovigilance activities, drug recalls, quality complaints, annual reports on drugs, cooperation with drug inspections, and cooperation with overseas inspections by the National Medical Products Administration of China, etc. This document is applicable to domestic responsible persons in clarifying their responsibilities, establishing a quality management system, and comprehensively fulfilling their obligations as domestic responsible persons. This document can also be used as a reference for independent legal entities that intend to become domestic responsible persons, as well as a basis for overseas marketing authorization holders to select domestic responsible persons.

Development Information

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