Skip to main content

Advertisement

SpringerLink
Log in

Regulation of Generic Drugs in China: Progress and Effect of the Reform of the Review and Approval System

  • Review Article
  • Published:
Journal of Pharmaceutical Innovation Aims and scope Submit manuscript

Abstract

Purpose

To provide insights into the trends of generic drug development and regulation in China.

Methods

This article reviews the process of generic drug review and approval system reform in China and conducts a data analysis on the application and approval of generic drugs from 2016 to 2020.

Results

In the process of reform, there are many changes in the definition of generic drugs, drug registration classification and ANDA acceptance criteria. A number of policies and regulatory documents were issued, a number of technical guidelines were developed, to cooperate with the reform. From 2016 to 2020, the review efficiency of the ANDA significantly improved, and the numbers of ANDA applications and approvals increased. ANDAs submitted by domestic applicants with RLDs marketed domestically (Registration Category 4) accounted for the largest proportion. The three therapeutic areas with the most ANDA applications were circulatory diseases, anti-infection and oncology. The applications for complex generic drugs accounted for only 7.9% of all ANDA applications.

Conclusions

The review quality and efficiency of the ANDA have been significantly improved in China. With the continuous deepening of reform and improvement of regulatory strategies, more high quality generic drugs will be brought to patients both in China and abroad.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4

Similar content being viewed by others

References

  1. Xu M, Zhai C, et al. Study of key factors influencing the quality of generic drug in China. Chin Pharm Affair. 2020;34(10):1130–44.

    Google Scholar 

  2. Qian G, Li X. The industrial development dilemmas and policy recommendations of generic drugs in China. Chin Health Econ. 2019;38(7):11–4.

    Google Scholar 

  3. The State Council, China. Opinions on reforming the review and approval system for drugs and medical device. 2015. https://www.nmpa.gov.cn/zhuanti/ypqxgg/ggzhcfg/20150818101201640.html (in Chinese). Accessed 10 Feb 2022.

  4. NMPA, China. Work plan for the reform of chemical drug registration classification (No.51), 2016. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20160309151801706.html (in Chinese). Accessed 10 Feb 2022.

  5. NMPA, China. Registration classification and requirements for application dossiers of chemical drugs (No.44), 2020. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20200630180301525.html (in Chinese). Accessed 10 Feb 2022.

  6. NMPA, China. New registration classification and requirements for application dossiers of chemical drugs (No.80,). 2016. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20160504175301774.html. (in Chinese). Accessed 10 Feb 2022.

  7. CDE, China. Guidance for the acceptance of chemical drug registration. 2020. https://www.cde.org.cn/main/news/viewInfoCommon/6386d7ca5a1515db4259acb1b8f16333 (in Chinese). Accessed 10 Feb 2022.

  8. Wang X, Wang L, Zheng X, Zheng Q. The reform of the Orphan Drug Assessment system in China. J Pharm Innov. https://doi.org/10.1007/s12247-021-09560-7. Published online: 21 May 2021.

  9. Zhang X, Li N, Ma Y, et al. Analysis on recent economic policies of pharmaceuticals in china and the prospect of pharmaceutical market of china in the next five years. World J Pharm Res. 2018;7(5):123–42.

    Google Scholar 

  10. CDE, China. Working procedures for supplementary data, 2020. https://www.cde.org.cn/main/news/viewInfoCommon/153db4152d7afa44d0b672c5aaa53b7b (in Chinese). Accessed 10 Feb 2022.

  11. CDE, China. Administrative measures for communication of drug development and technical review, 2020. https://www.cde.org.cn/main/news/viewInfoCommon/b823ed10d547b1427a6906c6739fdf89 (in Chinese). Accessed 10 Feb 2022.

  12. NMPA, China. Selection and determination procedures for reference preparations of chemical generic drugs (No.44), 2019. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20190328162401710.html (in Chinese). Accessed 10 Feb 2022.

  13. Wei L. Current status and market overview of special injections. Prog Pharm Sci. 2018;42(12):913–21.

    Google Scholar 

  14. CDE, China. Technical requirements for consistency evaluation of quality and efficacy of generic drugs for chemical injection (special injection). 2020. https://www.cde.org.cn/zdyz/domesticinfopage?zdyzIdCODE=bd48d9ea178b60d6d100848ca5a87b35 (in Chinese). Accessed 10 Feb 2022.

  15. CDE, China. Guideline for pharmaceutical research technology of chemical generic transdermal patch. 2020. https://www.cde.org.cn/main/news/viewInfoCommon/4fdc83d15725baf7960c60b965f51fee (in Chinese). Accessed 10 Feb 2022.

  16. CDE, China. Guideline for bioequivalence study of generic drugs of oral inhalation preparations. 2020. https://www.cde.org.cn/main/news/viewInfoCommon/e1fac37cca917e1d9355bb630e440c1a (in Chinese). Accessed 10 Feb 2022.

  17. CDE, China. Technical guideline for generic drug research of doxorubicin hydrochloride liposome injection. 2020. https://www.cde.org.cn/main/news/viewInfoCommon/548c025039cadecac94d0a45fce96d1b (in Chinese). Accessed 10 Feb 2022.

  18. CDE, China. Technical guideline for research on generic drugs of paclitaxel (albumin binding) for injection. 2020. https://www.cde.org.cn/main/news/viewInfoCommon/548c025039cadecac94d0a45fce96d1b (in Chinese). Accessed 10 Feb 2022.

  19. NMPA, China. The 2018 Drug Review Annual Report. 2021. http://www.cde.org.cn/news.do?method=largeInfo&id=cb377a202489c901 (in Chinese). Accessed 10 Feb 2022.

  20. FDA. Upcoming product-specific guidances for complex generic drug product development. 2021. https://www.fda.gov/drugs/guidances-drugs/upcoming-product-specific-guidances-complex-generic-drug-product-development. Accessed 10 Feb 2022.

  21. FDA. Introduction to complex products and FDA considerations. 2017. https://www.fda.gov/media/108937/download. Accessed 10 Feb 2022.

  22. Li X, Yang Y. The drug lag issue: a 20-year review of China. Investig New Drugs. 2021;39(5):1389–98.

  23. Shao L, Xu L, et al. Regulatory watch: innovative drug availability in China. Nat Rev Drug Discovery. 2016;15(11):739–40.

    Article  CAS  PubMed  Google Scholar 

  24. National Center for cardiovascular diseases, China. Annual Report on Cardiovascular Health and Diseases in China (2020). Science Press, 2021.

  25. Hussaarts L, Mühlebach S, et al. Equivalence of complex drug products: advances in and challenges for current regulatory frameworks. Ann N Y Acad Sci. 2017;1407(1):39–49.

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. School of Business Administration, Shenyang Pharmaceutical University, Shenyang, 110016, China

    Si Chen & Yue Yang

  2. Center for Drug Evaluation, National Medical Products Administration, Beijing, 100038, China

    Si Chen, Xin Chen, Mengsi Liu & Zhenyu Xu

  3. Institute of Regulatory Science, School of Pharmaceutical Sciences, Tsinghua University, Biomedicine Hall, Rm C104, Beijing, 100084, China

    Yue Yang

  4. Key Laboratory of Innovative Drug Research and Evaluation, National Medical Products Administration, Tsinghua University, Biomedicine Hall, Rm C104, Beijing, 100084, China

    Yue Yang

Authors
  1. Si Chen
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Xin Chen
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Mengsi Liu
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Zhenyu Xu
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Yue Yang
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Yue Yang.

Ethics declarations

Disclaimer

The views expressed in this article are those of the authors and do not necessarily reflect the official views of the National Medical Products Administration.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 (DOCX 20 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Chen, S., Chen, X., Liu, M. et al. Regulation of Generic Drugs in China: Progress and Effect of the Reform of the Review and Approval System. J Pharm Innov 18, 340–348 (2023). https://doi.org/10.1007/s12247-022-09655-9

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12247-022-09655-9

Keywords

Search

Navigation