Shanghai’s Medical Product Administration has unveiled a comprehensive set of 17 measures aimed at fostering a world-class business environment in the medical administration sector. The initiatives focus on enhancing service levels, advancing benchmarking reforms, and optimizing regulatory supervision.
Key measures include:
- Streamlined Services: Accelerating the registration and implementation of drugs and medical devices through a refined “one list, two optimizations” service mechanism tailored to meet enterprise needs for regulatory policies and technical evaluations.
- Optimized Registration Guidance: Enhancing guidance for innovative medical devices, including pre-application services for Class II devices undergoing special review processes, and implementing pre-examination for first-time registration materials.
- Proactive Cosmetics Guidance: Strengthening support services for cosmetic product regulation.
- Key Enterprise Support: Establishing a dynamic service package for key enterprises, implementing tailored policies for critical products.
- Registration Guidance Workstations: Launching Version 2.0 of the Guiding Opinions for Biomedical Product Registration Guidance Service Workstations to support innovative product development and provide daily consulting services.
- Clinical Trial Support: Improving capabilities for conducting international multicenter clinical trials and establishing a robust information-based supervision mechanism.
- Port Supply Policies: Exploring policies for the supply of drugs and medical equipment for international cruise ships at ports.
- Biological Product Production: Piloting segmented production processes for biopharmaceuticals with urgent clinical needs.
- Continuous Manufacturing Technology: Promoting the industrial application of advanced technologies in continuous pharmaceutical manufacturing.
- Drug Supplement Applications: Streamlining the process for optimizing supplementary drug applications.
- Medical Device Registration: Reducing the average technical evaluation time for Class II medical devices to 55 working days by the end of 2024.
- Intelligent Government Services: Enhancing the intelligence level of government services.
- Retail Pharmacy Supervision: Implementing “Internet plus” supervision to improve collaborative oversight across departments.
- Yangtze River Delta Collaboration: Promoting cross-regional cooperation in the supervision of drug production and cosmetic registrants.
- Credit Rating Supervision: Implementing dynamic classification and grading supervision based on credit and risk assessments.
- Compliance Guidelines: Providing risk warnings for common regulatory violations and promoting self-inspection among enterprises.
- In-Process Supervision: Enforcing a fault-tolerant mechanism for first violations and minimizing administrative penalties for minor infractions in the pharmaceutical sector.- Flcube.com
