China’s National Joint Procurement Office has issued a notification regarding the information change of selected drugs in the national centralized drug procurement. This notification allows for changes in drug marketing authorization holders, manufacturers, specifications, packaging, and enterprise names under certain conditions, while maintaining the selected status of the drugs. This move aims to enhance the flexibility and adaptability of the centralized procurement system, ensuring the continuity and stability of drug supply.
Key Policy Highlights
- Information Change Allowance
- Conditions: Under specific conditions, changes in drug-related information are permitted without losing the selected status.
- Purpose: To maintain the stability of the drug supply chain and adapt to market changes.
- Regulatory Compliance
- Material Review: The change applications are subject to strict verification to ensure compliance with regulatory standards.
- Market Implications
- Supply Stability: Ensures uninterrupted drug supply by allowing necessary information adjustments.
- Industry Adaptability: Provides flexibility for enterprises to respond to market dynamics while maintaining their position in the procurement system.
Policy Orientation and Industry Implications
The notification reflects China’s strategic focus on:
- Supply Chain Resilience: Prioritizing the stability and continuity of drug supply.
- Regulatory Flexibility: Adapting regulatory measures to support industry dynamics and market changes.
- Market Stability: Ensuring the centralized procurement system remains effective and responsive to industry needs.
Conclusion
China’s approach to allowing information changes in selected drugs under the centralized procurement system demonstrates a balance between regulatory rigor and industry flexibility. This policy supports the stability of the pharmaceutical market and ensures patient access to essential medications. Stakeholders should stay informed of these changes to maintain compliance and operational efficiency.-China Health Reform Pulse
Policy Source: https://www.smpaa.cn/gjsdcg/2025/03/26/16521.shtml