OBJECTIVES

: To understand how the CFDA priority review pathway speed up the regulatory approval of drugs addressing high clinical unmet need in China.

METHODS

: The study employed a pragmatic literature review to understand the impact of new priority review pathway implemented by the CFDA on regulatory approval of innovative therapies.

RESULTS

: In 2016, the CFDA implemented a priority review pathway for innovative medicines which treat serious illnesses, products in short supply, early generics, and drugs that have either been approved in the USA and EU or are undergoing review in those regions. Between March 2017 and January 2018, there were total of 14 drugs approved under the new pathway; among these two were approved for new indications and rest were innovative drugs. The average duration between CFDA nomination of eligible for priority review to actual approval was approximately 200 days. Lung cancer drug osimertinib was the first one to be approved via this pathway with only 21 days from priority review nomination to regulatory approval. Overall, the key drivers for the approval include high patient demand, addressing significant unmet need, clinical advantage over existing therapies, and precision medicine. Analysis of a list of drugs in China that underwent recent reimbursement negotiations revealed the average time lag between FDA and CFDA approval at 9.9 years. However, under the new pathway for the prioritized medicines, the difference is shortened to 6.7 years, representing significant improvement in regulatory approval time.

CONCLUSIONS

The priority review pathway has rewarded the development of new drugs for severe disease areas with high patient unmet needs. It has significantly shortened the regulatory approval timeline and provides substantial improvement in the availability of the innovative medicines in China.