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China, Pharma

Announcement of the 12th National Centralized Volume-Based Procurement of Pharmaceuticals

Announcement of the 12th National Centralized Volume-Based Procurement of Pharmaceuticals

China has further strengthened the legal framework governing national centralized pharmaceutical procurement through the Announcement on the 12th National Centralized Volume-Based Procurement of Pharmaceuticals. The measure sets out the eligibility criteria and regulatory obligations applicable to both domestic and foreign Marketing Authorization Holders (MAHs) participating in the procurement processThe new framework reinforces key regulatory compliance requirements, including GMP compliance, pharmaceutical traceability, intellectual property commitments, and comprehensive documentary obligations. For pharmaceutical operators, a clear understanding of these legal requirements is essential to ensure lawful market access and effective participation in China's public procurement system.