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Policy Analysis & Guidance: Yunnan’s Public Disclosure of Drug Attribute Changes

Yunnan’s Provincial Government Procurement and Tendering Center has released a public disclosure of changes to pharmaceutical attributes, effective immediately. The initiative aims to enhance transparency in drug classification and compliance, particularly for essential medicines under the national basic drug directory.

Policy Breakdown

Disclosure Mechanism: Changes to drug attributes, including reclassification from “non-essential” to “essential,” are publicly listed. Companies can query details via Yunnan’s centralized procurement platform.
Objection Process: Enterprises or individuals with concerns about the disclosed information have five working days to submit objections to designated regulatory departments.
Essential Drug Registration: Drugs classified as “essential” must complete a notification and commitment filing process with the Yunnan Provincial Drug Administration.

Market Implications
The policy reduces ambiguity in drug classification, potentially accelerating compliance timelines and improving regulatory predictability. Analysts at Yunnan Health Economics Institute estimate a 15–20% improvement in administrative efficiency for essential drug registrations.

Industry Impact
Pharmaceutical firms are urged to promptly address attribute changes to avoid disruptions in procurement processes. The move underscores Yunnan’s commitment to balancing regulatory rigor with industry accessibility.

Looking Ahead
As public supervision mechanisms expand, stakeholders should monitor how real-time updates and streamlined filing processes impact market dynamics. The next review cycle for drug attributes is expected in Q3 2025.-China Health Reform Pulse

Policy Source: http://www.ynyyzb.com.cn/detail.html?infoId=25217&CatalogId=3

Policy Analysis and Guidance: Guangdong’s Adjustment of Medical Supply Pricing

Guangdong Provincial Drug Exchange has announced an adjustment to the pricing of certain medical consumables on its third-party drug electronic trading platform. This initiative aims to optimize pricing rules, enhance price monitoring, and ensure fair and transparent transactions.

Key Policy Highlights

Pricing Adjustment
- Effective Date: The adjusted pricing for specific medical consumables will take effect from April 9, 2025.
- Product Details: Detailed information on the adjusted products is provided in the attachment for reference.
Preparation Requirements
- Transition Readiness: Relevant units need to prepare for online procurement and price transition of related products according to the actual situation.
Policy Background
- Basis: The adjustment is conducted in accordance with the “Notice on Optimizing and Perfecting the Listing Rules for Drugs and Consumables and Strengthening Price Monitoring” (粤医保函〔2023〕144号) and the “Announcement on the Implementation of Medical Consumable Listing Procurement on the Third-Party Drug Electronic Trading Platform of Guangdong Province”.

Policy Orientation and Industry Implications
The pricing adjustment policy reflects Guangdong’s strategic focus on:

Transparency: Enhancing transparency in medical consumable pricing through public disclosure.
Fair Pricing: Ensuring medical institutions can access products at fair and reasonable prices.
Market Efficiency: Promoting efficient distribution and procurement processes to support healthcare delivery.

Conclusion
Guangdong’s approach to adjusting medical consumable pricing sets a benchmark for regional medical product management, emphasizing transparency, fair pricing, and efficient distribution. Medical product enterprises should align with these guidelines to ensure smooth operations and contribute to healthcare efficiency.-China Health Reform Pulse

Policy Source: https://www.gdmede.com.cn/announcement/announcement/detail?id=1907730520356163584

Policy Analysis and Guidance: Qinghai’s Announcement on Medical Device Registration Changes and Extensions

Qinghai Provincial Drug Administration has issued an announcement regarding the registration changes and extensions for Class II medical devices. This initiative aims to ensure the compliance and quality of medical devices, supporting the healthy development of the industry.

Key Policy Highlights

Registration Changes and Extensions
- Purpose: To streamline the process for registration changes and extensions, ensuring medical devices meet updated safety and quality standards.
- Details: The announcement covers six medical device products, including changes to product structure, names, and technical requirements, as well as extensions for product registration.
Transparency and Compliance
- Public Disclosure: Detailed information on the products and changes is publicly available to enhance transparency and accountability.
- Regulatory Compliance: Ensuring all registered medical devices comply with national standards and regulations.
Industry Support
- Development: Supporting the innovation and development of the medical device industry through clear and efficient regulatory processes.
- Efficiency: Streamlining administrative procedures to reduce burdens and promote industry growth.

Policy Orientation and Industry Implications
The registration changes and extensions policy reflects Qinghai’s strategic focus on:

Quality Assurance: Ensuring medical devices meet updated safety and quality standards.
Transparency: Enhancing transparency through public disclosure of registration information.
Industry Growth: Supporting the innovation and sustainable development of the medical device sector.

Conclusion
Qinghai’s approach to medical device registration changes and extensions sets a benchmark for regional medical device regulation, emphasizing quality, compliance, and industry support. Medical device enterprises should align with these guidelines to ensure smooth operations and build public trust.-China Health Reform Pulse

Policy Source: http://ypjgj.qinghai.gov.cn/Article/FormDetailsYJJ?Article_ID=12091C32-B6CD-4B15-A439-BE5272243833