Strengthening China’s medical products regulatory system
Overview
The World Health Organization plays a pivotal role in supporting countries to strengthen their national regulatory systems and ensure equitable access to quality, safe, effective, and affordable medical and health products.
A 15-year successful collaboration between WHO and the Chinese national regulatory authority included an assessment against global benchmarks. WHO China has been actively involved in the preparation and assessment activities, and provided technical and administrative support to the assessments. WHO assessments performed in December 2010 and April 2014 showed that China’s regulatory system is not only functional but is also continually improving.
Following the successful model of the collaboration between WHO and Chinese authorities with respect to the vaccine regulatory system, Chinese authorities expressed their interest to extend collaboration to other product streams, particularly in medicines.
WHO and the China National Medical Products Administration (NMPA) continue to work together and support NMPA to become WHO listed Authorities.
Key facts
- The national regulatory authority of China was declared ‘functional’ after meeting WHO indicators for a functional vaccine regulatory system following assessment in 2010.
- The Chinese regulatory authority on vaccine regulation was declared ‘functional’ at maturity level three after the WHO benchmarking assessment in 2014.
- In 2013, the Japanese Encephalitis vaccine was the first Chinese-manufactured vaccine to be prequalified by WHO after the functionality of the regulatory authority was declared.
- A new Declaration of Intent was signed between WHO and NMPA in October 2019 to reiterate the collaboration and continuation of regulatory strengthening.