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China: Regulations on the Supervision and Administration of Drug Production for Export

Updated on : 03-03-2025

China: Regulations on the Supervision and Administration of Drug Production for Export

The purpose of the "Regulations on the Supervision and Administration of Drug Production for Export" is to regulate the drug manufacturing activities of Chinese manufacturers exporting drugs to other countries or regions, and to require the implementation of GMP. It mainly includes  the following contents: general provisions, basic requirements, entrusted manufacturing for export, export drug archives, export certification documents (general requirements for export certification documents, Certificate of a Pharmaceutical product, Written confirmation for active substances exported to EU), supervision and management, and supplementary provisions. 

Download: China: Regulations on the Supervision and Administration of Drug Production for Export

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