An overview of expedited approaches in China’s drug review and approval regulation

doi:10.5246/jcps.2017.06.050

Abstract

Abstract:

Nowadays, CFDA has released a series of reform documents in drug registration review system, which may optimize the new drug evaluation model to accelerate the development of drugs. In this review, we summarized the qualifications and features of expedited approaches in drug review and approval in China, and compared these approaches with FDA. In conclusion, the expedited programs of drug approval in China have been gradually established and translated into policy benefits for drug makers and patients.

Key words: Priority review, Drug review, Drug approval regulation

CLC Number:

R951

Supporting:

Tian Tian. An overview of expedited approaches in China’s drug review and approval regulation[J]. Journal of Chinese Pharmaceutical Sciences, 2017, 26(6): 455-459.

References

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