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The drug lag issue: a 20-year review of China

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Summary

China has been criticized for the long drug delay for a long time. There was little understanding of Chinese drug lag formation from the investigational new drug (IND) submission to the new drug application (NDA) approval. Therefore, we analyzed the problem of drug lag in China cumulating from the clinical trial starting lag to the lags formed during the regulatory process and discerned the key underlying factors. After investigating the availability in China of new molecular entities (NMEs) approved by the Food and Drug Administration (FDA) between 1999 and 2019, we find that even though cutting regulatory process could reduce the approval lag, the clinical trial starting time in China is more important in drug lag reduction than shortening development time and review time. The reduction of the regulatory process also needs continuous efforts by defining the clinical value based on the medical needs, regulatory procedure harmonization, and intensive discussions between applicants and regulators during the drug development process. Meanwhile, proactive approaches should be taken to encourage developing the first generics in China. More importantly, enhancing domestic research and development capabilities is still the key to cutting the drug lag. Moreover, the China National Medical Product Administration (NMPA) should attach importance to the accumulation of regulation experience on innovative drugs and transform the style of regulating generics to new drugs.

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Acknowledgments

We thank Ph.D. Aslam Fahmida for her comments on the manuscript.

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Authors and Affiliations

  1. International Food & Drug Policy and Law Research Center, School of Business Administration, Shenyang Pharmaceutical University, Shenyang, China

    Xiaoyu Li & Yue Yang

  2. Institute of Regulatory Science, Tsinghua University, Biomedicine Hall, Rm C104, Beijing, 100084, China

    Yue Yang

Authors
  1. Xiaoyu Li
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  2. Yue Yang
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Contributions

XL wrote the manuscript, performed the research, and analyzed the data. YY and XL designed the research. The authors read and approved the final manuscript.

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Correspondence to Yue Yang.

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Li, X., Yang, Y. The drug lag issue: a 20-year review of China. Invest New Drugs 39, 1389–1398 (2021). https://doi.org/10.1007/s10637-021-01117-2

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