Category Archives: Shanghai

Policy Analysis & Guidance: Shanghai Suspends Procurement Qualification for Non-Compliant Drugs

Shanghai’s Centralized Medicine Bidding and Procurement Office announced on April 15 the suspension of procurement qualifications for certain drugs due to non-compliance with pricing regulations. The action targets Difenidol Hydrochloride Tablets produced by Renhetang Pharmaceutical Co., Ltd., effective from April 15, 2025, at 24:00.

Policy Breakdown and Market Implications

Non-Compliance Identified: The suspension stems from the producer’s failure to adjust prices in line with national medical insurance bureau requirements.
Product Details: The affected product is Difenidol Hydrochloride Tablets (25mg*12 tablets/board, aluminum-plastic packaging).
Regulatory Basis: The move aligns with national healthcare security policies aimed at ensuring drug pricing transparency and compliance.

Industry Impact
This action serves as a clear warning to pharmaceutical companies on the importance of adhering to pricing guidelines. Manufacturers are urged to review and adjust their pricing strategies to avoid procurement disruptions.

Looking Ahead
Stakeholders should monitor how such enforcement actions influence market dynamics and pricing strategies among pharmaceutical firms. The long-term goal is to foster a fair and regulated procurement environment.-China Health Reform Pulse

Policy Source: https://www.smpaa.cn/xxgk/gggs/2025/04/15/16814.shtml

Policy Analysis & Guidance: China’s Drug Procurement Office Adjusts Pricing for Selected Products

China’s National Joint Procurement Office (NJPO) has issued a notice correcting the pricing of Pregabalin Oral Solution supplied by KBN-Zhejinag Pharmaceutical Co., Ltd. The revised price for the 473ml:9.46g*1(100ml) specification is set at 11.78 RMB, effective immediately.

Policy Breakdown

Price Correction: The updated price reflects a more accurate valuation of the product within the centralized procurement framework.
Product Details: The correction applies specifically to the oral solution formulation, with no changes to other entries in the national procurement supply list.
Market Implications: The adjustment ensures competitive pricing for healthcare providers and patients, aligning with the program’s goal of cost efficiency.

Industry Impact
Pharmaceutical companies participating in the centralized procurement program are advised to review their pricing strategies to maintain competitiveness. The move underscores the NJPO’s commitment to transparency and accuracy in drug pricing.

Looking Ahead
Stakeholders should monitor future pricing adjustments and supply list updates to stay informed of changes impacting market dynamics and procurement strategies.-China Health Reform Pulse

Policy Source: https://www.smpaa.cn/gjsdcg/2025/04/10/16525.shtml

Policy Analysis & Guidance: China’s Drug Procurement Office Cancels Qualification for Non-Compliant Drug

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