Medical Education Management ›› 2020, Vol. 6 ›› Issue (3): 297-303.doi: 10.3969/j.issn.2096-045X.2020.03.022

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Evolution of drug registration classification and innovation of China′s drug supervision concept ——Comparison of new and old Drug Registration Regulations

Guo Xiangyu   

  1. School of Pharmaceutical Sciences, Capital Medical University, Beijing 100069, China
  • Received:2020-04-14 Online:2020-06-20 Published:2020-07-13

Abstract: The current classification of the latest drug registration not only reflects the international standards, but also pays attention to the difference between chemical drugs and biological products. More importantly, it takes into account China's national conditions and the characteristics of traditional Chinese medicine. The new registration classification system will definitely improve the level of China's drug registration management, and balance the interests of original drug companies, generic drug companies, patients and all parties in the society, and will play an important role in guiding and promoting the healthy development of China's pharmaceutical industry.

Key words: drug registration classification,  interest balance,  innovation of supervision concept

CLC Number: