Category Archives: Shanghai

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

Policy Analysis & Guidance: Shanghai’s New Medical Insurance Payment Qualification Management Rules

Shanghai has launched a pioneering initiative to strengthen oversight of its medical insurance fund by implementing a graded scoring system for healthcare professionals. The new Detailed Rules for the Management of Medical Insurance Payment Qualification (Trial implementation), effective immediately, extend regulatory scrutiny from institutions to individual practitioners, marking a shift toward dual control of medical costs and service quality.

Policy Background

National Mandate: The move aligns with the State Council’s 2020 guidance to expand medical insurance supervision to individual medical staff and emphasize performance metrics.
Regulatory Framework: Jointly issued by the National Medical Insurance Administration, National Health Commission, and National Medical Products Administration, the policy mandates accountability for fund usage while deterring fraud.

Key Mechanisms

Automatic Qualification: Healthcare workers gain payment eligibility via service agreements with designated medical institutions, bypassing administrative licensing.
Driving-License-Style Scoring: Violations incur points akin to traffic offenses. Serious breaches (e.g., fraud) result in immediate disqualification for three years, while minor offenses serve as warnings.
Appeal and Remediation: Professionals can contest scores within 10 working days or mitigate penalties through policy exams and participation in insurance management initiatives.

Market and Compliance Impact
The policy introduces granular accountability, potentially reducing fraudulent claims by 15–20%, according to analysts at Shanghai Health Economics Institute. It also incentivizes continuous education among medical staff, with remediation measures like score reduction for passing policy exams.

Industry Reaction
“While the scoring system raises compliance stakes, it clarifies regulatory expectations, reducing operational ambiguity,” said Dr. Wang Li, compliance director at Shanghai United Family Hospital.

Global Context
China’s medical insurance fund reached RMB 3.7 trillion in 2024. Shanghai’s approach mirrors international best practices in healthcare fund management, potentially influencing policies across Asia-Pacific markets.

Looking Ahead
The trial period concludes in 2027, with nationwide adoption possible if Shanghai’s model proves effective. Investors should monitor how remediation mechanisms balance punitive and educational objectives.

For detailed implementation guidelines, refer to the official policy document.-China Health Reform

Policy Source: https://ybj.sh.gov.cn/zcjd/20250403/321fead4718e4d09ad77dff0c9769da6.html