On December 30, the NMPA (National Medical Products Administration) issued the 14th Five-Year Plan for National Drug Safety and Promotion of High Quality Development. The Five-Year Plan sets goals to (i) achieve high quality industrial production under improved regulatory monitoring; (ii) reach global standard of vaccine regulations; (iii) adopt traditional Chinese medicine in innovative developments; (iv) make vast improvements with professional talents acquisition; and (v) strengthen technical support capabilities.
Highlights
The 13th Five-Year Plan was a success for the following achievements:
- Implementation of the newly revised law on the supervision and administration of medical devices (Order 739) and the new administrative measures for the registration and filing of medical devices (No.47-2021) and IVDs (No.48-2021).
- Introduction of the Cosmetic Supervision and Administration Regulation (CSAR).
- Implementation of the 2020 edition of the Pharmacopoeia
- Over 90% of the total medical device regulatory standards published in China aligns with international standards
According to the 14th Five-Year Plan,
- 2650 standards will be implemented or revised for pharmaceuticals, medical devices and cosmetics whilst 480 technical review guidelines will be added
- Random inspection will be conducted annually on approximately 50 different categories of medical devices that are considered to be high risk, largely consumed daily, and a great concern to the community.
- QMS inspection will be conducted at least once a year for manufacturers producing sterlized and implantable medical device products.
- 500 medical device regulations will be issued and revised by 2025. Mainly, mandatory standards focusing on health and safety as well as recommended standards for high-quality industrial improvement.
- Increase registration capability for new innovative drugs and medical devices from overseas to launch simultaneously in China
- Establish a complete system for better adverse event monitoring and reporting on drugs, medical devices and cosmetics.
- Keep up with the evolution of global technology by setting up laboraties focusing in the field of artificial intelligence, biological materials and in vitro diagnostic reagents.
By Julie Zhang and Jacky Li. Contact Cisema if you would like to learn more.
