The 14th Five-Year Plan for Drug Supervision Network Security and Information Construction in China issued (No.23-2022) by the NMPA on May 11, 2022, aims to:
- Increase the capability for safety risk management on drug products
- Optimize the strategic plan for intelligence supervision development on drugs
- Modernize the drug regulatory framework with effective use of information technology
- Promote the adaptation of innovative technology in the market surveillance of drugs
Review of the 13th Five-Year Plan
Since the release of the Action Plan of NMPA on Accelerating the Smart Regulation of Medicines, all Chinese drug regulatory departments have been actively supporting the development of smart market surveillance on drugs. As of today, the informatization of the basic infrastructure for drug surveillance is complete whilst national and provincial data centers, as well as regulatory boards are now competently available in China. These important developments set up a good foundation as the NMPA prepare to move forward to the 14th Five-Year Plan.
Objectives of the 14th Five-Year Plan
According to the 14th Five-Year Plan for Drug Supervision Network Security and Information Construction in China, the NMPA will focus on accomplishing the following 16 missions:
- Upgrade the capabilities for:
- smart surveillance on drug products
- smart surveillance on medical device products
- smart surveillance on cosmetic products
- product traceability with an information-based system
- monitoring adverse drug reactions with a complete national system
- the supervision of professionals (inspectors, licensed pharmacist, etc.) under a unified system / platform
- the use of mobile applications in the market surveillance of drugs, cosmetics, etc.
- Upgrade the government capabilities by:
- strengthening online services and administrative work enhancement
- establishing a smart drug surveillance platform to be shared by the entire nation
- Facilitate the use and integration of data resources for market surveillance
- Refine the structure of national and provincial data centres
- Improve the system for drug filing
- Create a system for drug credibility and safety information
- Strengthen the digital base for intelligent drug supervision
- Refine the current system for the implementation / amendment of Chinese regulatory standards
- Upgrade the NMPA cloud system
- Improve cybersecurity, data security, and operating platforms
- Refine the NMPA cybersecurity system
- Refine the operating platforms for security management
By Yu and Jacky. If you would like to learn more about Measures for the Administration of Drug Registration or our registration and CRO services for pharmaceuticals, medical devices, IVDs, cosmetics, health foods, industrial or consumer goods contact Cisema.
