Category Archives: Other

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

Policy Analysis & Guidance: Yunnan’s Routine Drug Listing Transparency

Yunnan’s Provincial Government Procurement and Tendering Center has announced the public disclosure of registration information for routine drug listings (Batch 20250407). The initiative aims to enhance transparency and efficiency in the province’s drug procurement process, allowing enterprises to query details via designated platforms.

Policy Breakdown

Disclosure Mechanism: Companies can access registration information through Yunnan’s Drug Centralized Procurement Platform or via a direct link provided by the provincial medical insurance bureau.
Non-Result Announcement: This disclosure is informational only and does not represent final approval. Enterprises are advised to await official review results before preparing Objection materials.
Compliance Focus: The policy emphasizes procedural transparency, reducing administrative burdens while maintaining strict oversight post-approval.

Market Implications
The initiative could streamline interactions between pharmaceutical firms and provincial authorities, potentially accelerating market entry timelines by 10–15%. Analysts at Yunnan Healthcare Institute highlight improved predictability as a key benefit for multinational and domestic players alike.

Industry Impact
Pharmaceutical companies operating in Yunnan are encouraged to familiarize themselves with platform navigation protocols to ensure timely information retrieval. The policy underscores Yunnan’s commitment to balancing regulatory rigor with industry convenience.

Looking Ahead
As platform functionality expands, stakeholders should monitor whether additional drug categories or real-time status updates are incorporated. The next review cycle is expected in Q3 2025.-China Health Reform Pulse

Policy Source: http://www.ynyyzb.com.cn/detail.html?infoId=25238&CatalogId=3

Policy Analysis & Guidance: Yunnan’s Public Disclosure of Medical Consumable Price Reductions

Yunnan’s Provincial Government Procurement and Tendering Center has initiated a public disclosure process for enterprise-initiated price reductions on medical consumables. The move aims to enhance price transparency, foster market competition, and ultimately reduce healthcare costs for patients.

Policy Breakdown

Disclosure Mechanism: Enterprises that have applied for price reductions are publicly listed, allowing stakeholders to review and supervise the process.
Objection Period: A five-working-day window is provided for enterprises or individuals to raise objections to the disclosed price adjustments.
Contact Channels: Clear contact information is provided for both procurement and regulatory departments to ensure smooth communication.

Market Implications
The policy is expected to intensify price competition among medical consumable suppliers, potentially leading to broader cost reductions across the healthcare supply chain. Analysts at Yunnan Health Economics Institute estimate that visible price adjustments could drive down procurement costs by 12–18% in the medium term.

Industry Impact
Medical consumable manufacturers are encouraged to proactively adjust pricing strategies to maintain market share amid increased transparency. The policy also underscores the provincial government’s commitment to balancing affordability with quality assurance.

Looking Ahead
As public oversight mechanisms expand, stakeholders should monitor how real-time price disclosures impact market dynamics and competitive behavior. The next review cycle for price adjustments is expected in Q3 2025.-China Health Reform Pulse

Policy Source: http://www.ynyyzb.com.cn/detail.html?infoId=25214&CatalogId=3