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Research on the Problems and Countermeasures of Mah in China's Drug Marketing Authorization Holder System

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DOI: 10.23977/medcm.2021.030201 | Downloads: 8 | Views: 871

Author(s)

Yujie Wang 1, Mei Wang 1, Yi Liang 1

Affiliation(s)

1 School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, Jiang Su., 211198, China

Corresponding Author

Yi Liang

ABSTRACT

To study the strategies for better implementation of China's drug listing holder system. Method: By comparing the implementation of the MAH system for drug marketing license holders at home and abroad, analyze the problems existing in each link of the system in the pilot implementation of the system in China and propose targeted improvement measures. Conclusion: It is recommended to learn from developed countries' mature experience to make the drug marketing authorization holder system a policy dividend for promoting the scientific and technological progress and long-term development of the pharmaceutical industry.

KEYWORDS

Marketing authorization holder, Pharmaceutical industry, Drug registration

CITE THIS PAPER

Yujie Wang ,Mei Wang ,Yi Liang. Research on the Problems and Countermeasures of Mah in China's Drug Marketing Authorization Holder System. MEDS Chinese Medicine (2021) 3: 1-4. DOI: http://dx.doi.org/10.23977/medcm.2021.030201.

REFERENCES

[1] Wang Chenguang. Drug marketing authorization holder system-a breakthrough in the reform of China's drug registration system. China Food and Drug Supervision[J]. 2016(07)
[2] General Office of the State Council.  "The Pilot Program of the Drug Marketing Authorization Holder System" [S]. 2016.
[3] Order of the President of the People's Republic of China. Drug Administration Law of the People's Republic of China. [EB/OL]. (2019.08.26). [2019.09.25] http://www.gov.cn/xinwen/2019-08/26 /content_5424780.htm].
[4] Zhao Na and Hu Xiaoshu. Research and analysis of EU drug marketing authorization system and its enlightenment to China.Pharmaceutical and Clinical Research[J], 2016, 24(5):429-432.
[5] Welfare and Health Care. The ethical policy of the Department of Human Health and Human Resources Research [EB/OL]. [2017-09-01]
[6] Han Qiaqia Zhang Qiu. Research on the implementation and countermeasures of the drug marketing authorization holder system in China . China Journal of New Drugs[J]. 2019, 05-0593-05.
[7] Huang Yulan. Comparison of domestic and foreign drug marketing authorization systems. West China Pharmaceutical Journal[J]. 2017(03)
[8] Xia Qirui. The development process of the MAH system in China and the problems in the pilot process. ShangQing[J] 2017, 29( 38): 45.
[9] You Xiaomin, Zong Maomao, Yang Yue. Research on the Responsibility Agreement of Entrusted Production under the Drug Marketing Authorization System. Journal of Shenyang Pharmaceutical University[J]. 2016(08)
[10] Dou Jie. MAH "Equal Responsibility, Power" Reform Test [N]. China Medical News. 2018-08-14 (006)
[11] Wang Yiyi. New results available. MAH system empowers new drug research and development . China Medical News[N]. 2018-10-09 (006)

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