Improvement and Discussion of Review Model for New Drugs in America

Abstract

Abstract: Objective To provide references for Chinese review model for new drugs. Methods Improved review model for NMENDAs and Original BLAs in PDUFAV was briefly introduced, assessed and analyzed. We explored the way of enhancing communication, review transparency and first-cycle approval rate and some revelations were put forward. Results The new review model adjusts PDUFA review timelimit and gives applicants and review teams enough time to improve and review applications respectively. Milestone meetings offer two-way communication opportunities for them. The third-party assessment shows that new review model promoted review process, improved review transparency and first-cycle approval rates and the review process is more predictable, especially for applications with special designations, such as Breakthrough Therapy and Fast Track. Conclusion When considering new drug review model, we should guarantee adequate review resources, control key review steps and enhance communication between applications and reviewers to improve the efficiency and effectiveness of first-cycle review.

Key words: PDUFAV, new drug review model

CLC Number:

GAO Jing, YANG Yue. Improvement and Discussion of Review Model for New Drugs in America[J]. Chinese Journal of Pharmacovigilance, 2015, 12(8): 471-475.

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