WANG YT,¹ SHEN YW,¹ WANG JW,¹ ZHOU ZC,¹ ZHANG J,¹ ZHAO HC,²

¹Tianjin International Joint Academy of Biomedicine, Tianjin China ,²Tianjin Academy of Science and Technology for Development, Tianjin, China

OBJECTIVES

In 2016, CFDA(the former name of the NMPA) announced a new ‘priority review’ process to address the legacy problems of the backlog of drug registration and the procrastinated marketing of new drugs. A long-awaited update to the National Reimbursement Drug List (NRDL) was completed in 2017, some new drugs with a focus on major illnesses had been added to the list. This study evaluate the NMPA priority review designations from 2016 to 2019 and how these have translated into reimbursement and patient access.

METHODS

Through a search of CDE's official website and the databases of pharmaceutical companies, we analyzed China’s drug approval via Prioritized review and access to NRDL from 2016 to 2019.

RESULTS :

Between 2016 and 2019, a total of 206 drugs (in generic terms) were expedited for marketing approval via Prioritized review process by the NMPA, including 161 chemical drugs, 44 biological products and 1 traditional Chinese medicine. The most represented therapeutic area is oncology, which received 29% of all priority review designations, followed by vaccines for infectious diseases(18%), and neuroscience(11%). 59% of these drugs are exclusive drugs, including 83 imported drugs and 38 domestic drugs. Of the 206 drugs, 70 kinds of drugs are included on the 2017 and 2019 NRDL.

CONCLUSIONS

In conclusion, our findings suggest that China's drug review and approval and reform of the health insurance system have made more exclusive drugs available, benefiting more people. However, there are no statistics on the decline in the prices of these drugs after they had added to the reimbursement list and need further investigation.