Regulatory reforms in China: Strengthening excipient quality and accession to PIC/S
Abstract
Among the science- and risk-based regulatory reforms currently underway in China, new legislation came into force on 1 January 2026 to strengthen the quality supervision of pharmaceutical excipients and pharmaceutical packaging materials. Manufacturers are required to have a comprehensive and robust quality management system in place. The 2025 edition of the Chinese Pharmacopoeia also increased the focus on excipients, introducing 52 new monographs and revisions to 136 monographs. In addition, China’s international harmonisation efforts include its accession to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) as a full member.
This article explores these developments.
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