China’s National Joint Procurement Office (NJPO) has canceled the centralized procurement qualification of Peramivir Injection, produced by Shanxi Yanghe Pharmaceutical Technology Co., Ltd. and entrusted to Shanxi Guorun Pharmaceutical Co., Ltd., following a regulatory crackdown on non-compliant production practices.

Policy Breakdown

• Non-Compliance Identified: The National Medical Products Administration (NMPA) found the drug to violate Good Manufacturing Practice (GMP) standards, leading to a production suspension order.
• Penalties Imposed: Both companies involved were added to a “blacklist” and barred from participating in national drug procurement activities until October 2026.
• Substitution Mechanism: Provinces affected by the disqualification must activate backup supply procedures as per procurement guidelines.

Market Implications
The decision underscores China’s zero-tolerance policy for quality violations, potentially delaying market access for non-compliant drugs by 12–18 months. Analysts at China Healthcare Regulatory Institute highlight the move as a deterrent to substandard production practices.

Industry Impact
Pharmaceutical firms are urged to prioritize GMP compliance to avoid disruptions in supply chains and procurement qualifications. The incident serves as a reminder of the risks associated with contract manufacturing arrangements.

Looking Ahead
The NJPO is expected to intensify audits of contract manufacturing relationships, with a focus on quality system alignment. Stakeholders should monitor how substitution procedures impact regional drug availability and pricing.-China Health Reform Pulse

Policy Source: https://www.smpaa.cn/gjsdcg/2025/04/07/16524.shtml