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National ADR Monitoring System in China

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Abstract

It has been more than 25 years since an adverse drug reaction (ADR) monitoring agency was first established in China. In the past few years, the National ADR Monitoring System (NADRMS) has developed rapidly in the country. However, this system has not been reviewed in detail in the literature. Our aim was to demonstrate how individual case safety reports (ICSRs) are reported and evaluated and how data quality control is achieved in China. We also aimed to discuss the present status and future of NADRMS. We reviewed the relevant regulations and literature around ADR reporting in China. ADR report collection tools in China have gone through three phases, namely paper-based reporting, software-based reporting using standalone computers, and online reporting. Nowadays the online reporting system plays an important role in China and the number of ADR reports has rapidly increased. NADRMS is similar to most of the ADR reporting systems around the world, but also has its own unique characteristics such as four levels of monitoring agencies. In summary, there is still a long way to go for China to establish a high-level ADR monitoring system to ensure drug safety.

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Acknowledgments

We would like to extend our special gratitude to Marie Lindquist and Zhurong Liu, from the Uppsala Monitoring Center for helpful comments on earlier versions of this paper.

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Authors and Affiliations

  1. National Center for ADR Monitoring, Beijing, China

    Yongfang Hou, Xinling Li & Guizhi Wu

  2. Department of Health Statistics, Second Military Medical University, Shanghai, China

    Xiaofei Ye

Authors
  1. Yongfang Hou
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  2. Xinling Li
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  3. Guizhi Wu
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  4. Xiaofei Ye
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Corresponding authors

Correspondence to Guizhi Wu or Xiaofei Ye.

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No sources of funding were used to assist in the preparation of this review.

Conflict of interest

Yongfang Hou, Xinling Li, Guizhi Wu, and Xiaofei Ye have no conflicts of interest that are directly relevant to the content of this review.

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Hou, Y., Li, X., Wu, G. et al. National ADR Monitoring System in China. Drug Saf 39, 1043–1051 (2016). https://doi.org/10.1007/s40264-016-0446-5

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  • DOI: https://doi.org/10.1007/s40264-016-0446-5

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