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Reforming China's drug regulatory system

Nature Reviews Drug Discovery volume 17, pages 858–859 (2018)Cite this article

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Phase 1: creating an efficient process

The first phase of reforms focused on the creation of an efficient and responsive review and regulatory process. A major part of this effort included clearing the severe registration backlog of drug applications (including clinical trial and marketing applications for both new drugs and generics), which reached its peak at 22,000 in mid-2015. On 22 July 2015, the China Food and Drug Administration (CFDA) mandated the self-examination and inspection of clinical trial data for 1,622 drug registration applications. The sweeping self-inspection programme was rolled out in waves and was followed by on-site inspection of drug clinical data of the remaining applications, which accounted for ∼22% of the total of 2,033 drug applications notified by the CFDA, deducting ∼3% exempted from clinical trials and ∼65% withdrawn. This stringent policy was a successful effort to crack down on data fraud and ensure data authenticity and integrity, as well as to relieve pressure to help achieve the goal of eliminating the massive backlog of drug registration applications by the end of 2016. Further measures were also taken to resolve the backlog and improve efficiency. The CFDA increased the drug registration fee and expanded its review teams. The adoption of a filing system of bioequivalence studies for chemical drugs, the establishment of a clinical value-based priority review system, the identification of redundant generic applications, the rejection of deficient applications and an enhanced communication and appeal mechanism between the Center for Drug Evaluation (CDE) and drug sponsors also took effect. As a result, the backlog of registration applications was nearly cleared by the end of 2017.

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Figure 1: Timeline of China's drug regulatory system reform.

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Authors and Affiliations

  1. Fudan Center for Study of Pharmaceuticals and Healthcare Strategy, Pudong, Shanghai, China

    Lili Xu & Liming Shao

  2. Shanghai Association of Food and Drug Safety, Xuhui, Shanghai, China

    Huijun Gao

  3. Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, MA, USA

    Kenneth I. Kaitin

Authors
  1. Lili Xu
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  2. Huijun Gao
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  3. Kenneth I. Kaitin
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  4. Liming Shao
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Correspondence to Liming Shao.

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The authors declare no competing financial interests.

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China's drug regulatory system reform timeline (May 2015 to May 2018)* (PDF 108 kb)

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Xu, L., Gao, H., Kaitin, K. et al. Reforming China's drug regulatory system. Nat Rev Drug Discov 17, 858–859 (2018). https://doi.org/10.1038/nrd.2018.150

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