Category Archives: Other

Policy Analysis and Guidance: Zhejiang Provincial Drug Administration’s Major Administrative Decision-Making Plan for 2025

The Zhejiang Provincial Drug Administration has released its 2025 Major Administrative Decision-Making Plan, outlining key initiatives aimed at enhancing drug and cosmetic safety, strengthening credit management systems, and advancing regulatory mechanisms. This policy framework reflects the province’s commitment to aligning with national regulatory standards while fostering innovation and compliance within the pharmaceutical and cosmetics industries.

Key Policy Initiatives

Zhejiang Drug Safety “15th Five-Year” Plan
- Objective: Establish a comprehensive safety framework for the pharmaceutical sector, covering drug production, distribution, and quality control.
- Implementation: Led by the Planning, Finance, and Technology Department, the plan will undergo public consultation, expert review, and legal scrutiny, with completion slated for June 2026.
- Impact: Expected to streamline regulatory processes and enhance transparency, supporting long-term industry growth and consumer protection.
Credit Management System for Drug Manufacturers
- Objective: Introduce a credit evaluation mechanism to incentivize compliance and penalize violations among drug producers.
- Implementation: Managed by the Drug Production Supervision Department, the system will integrate public feedback, competitive fairness reviews, and legal validation, targeting completion by December 2025.
- Impact: Promote accountability and elevation industry standards, aligning with national credit system construction initiatives.
Credit Evaluation Framework for Cosmetic Enterprises
- Objective: Develop a credit scoring system for cosmetic registrants, filers, and manufacturers to ensure quality and safety.
- Implementation: Spearheaded by the Cosmetics Supervision Department, the framework will incorporate public input, competitive reviews, and legal checks, aiming for completion by August 2025.
- Impact: Enhances regulatory oversight and consumer confidence in the cosmetics sector.

Policy Orientation and Industry Implications
The 2025 plan underscores Zhejiang’s strategic focus on:

Regulatory Modernization: Transitioning toward data-driven and credit-based supervision.
Industry Compliance: Encouraging enterprises to prioritize quality and safety through transparent evaluation systems.
Public Engagement: Prioritizing stakeholder input to ensure policies reflect practical industry needs.

Conclusion
Zhejiang’s proactive regulatory approach positions the province as a leader in pharmaceutical and cosmetics governance. Companies operating in these sectors should prepare for heightened compliance expectations and leverage the upcoming frameworks to strengthen market credibility and operational efficiency.-China Health Reform Pulse

Policy Source: http://mpa.zj.gov.cn/art/2025/3/31/art_1228989285_58939952.html

Policy Analysis and Guidance: Sichuan’s Class II Medical Device Initial Registration Product Directory

Sichuan Provincial Drug Administration has released the initial registration product directory for Class II medical devices for March 2025. This initiative aims to enhance transparency, ensure compliance, and support the development of the medical device industry.

Key Policy Highlights

Registration Information Disclosure
- Purpose: To provide the public with accurate and timely information on newly registered Class II medical devices.
- Details: The directory includes detailed registration information for multiple medical device companies, such as Chengdu Kanghuijing Technology Co., Ltd. and Wangcheng Medical Technology (Chengdu) Co., Ltd.
Regulatory Compliance
- Standards: Ensuring all registered medical devices comply with national standards and regulations.
- Transparency: Making registration information publicly available to enhance trust and facilitate industry supervision.
Industry Support
- Development: Supporting the innovation and development of the medical device industry through clear and efficient regulatory processes.
- Efficiency: Streamlining the registration process to reduce administrative burdens and promote industry growth.

Policy Orientation and Industry Implications
The initial registration product directory policy reflects Sichuan’s strategic focus on:

Transparency: Ensuring public access to accurate and timely registration information.
Compliance: Strengthening regulatory frameworks to ensure product safety and quality.
Industry Growth: Supporting the innovation and sustainable development of the medical device sector.

Conclusion
Sichuan’s approach to Class II medical device initial registration sets a benchmark for regional medical device regulation, emphasizing transparency, 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://yjj.sc.gov.cn/scyjj/c103181/2025/4/1/53dabb2afc2547e4bbc9a1ed78f3ce27.shtml

Policy Analysis and Guidance: Yunnan’s Announcement on Credit Rating Notifications for Dishonest Enterprises

Yunnan Provincial Government Procurement and Tendering Center has issued an announcement regarding credit rating notifications for dishonest enterprises involved in pharmaceutical commercial bribery. This initiative aims to strengthen the regulation of the pharmaceutical industry, combat commercial bribery, and maintain market order and fair competition.

Key Policy Highlights

Credit Evaluation
- Objective: To evaluate the credit of enterprises involved in pharmaceutical commercial bribery cases and issue corresponding ratings.
- Basis: The evaluation is conducted in accordance with the “Operational Norms for Pharmaceutical Price and Tendering Credit Evaluation (2020 Edition)”.
Notification and Collection
- Process: Enterprises listed in the announcement must collect their credit rating notifications by April 9, 2025.
- Location: Notifications can be collected at Room 402, Transaction Building, No. 269 Kefa Road, Kunming High-Tech Zone.
Consequences of Non-Compliance
- Deadline: Failure to collect the notification by the specified date may result in adverse consequences for the enterprises involved.

Policy Orientation and Industry Implications
The credit rating policy reflects Yunnan’s strategic focus on:

Market Regulation: Combating commercial bribery to maintain a fair and orderly market environment.
Transparency: Enhancing transparency in the pharmaceutical industry through credit evaluations.
Compliance: Encouraging enterprises to adhere to legal and ethical standards in their operations.

Conclusion
Yunnan’s approach to credit rating notifications for dishonest enterprises sets a benchmark for regional pharmaceutical industry regulation, emphasizing transparency, compliance, and market integrity. Enterprises in the sector should align with these guidelines to maintain compliance and contribute to a fair market environment.-China Health Reform Pulse

Policy Source: http://www.ynyyzb.com.cn/detail.html?infoId=25193&CatalogId=3