• Ashok Kumar Nadipineni
  • Dileep K. G.
  • Ravindra C. K.
  • Suthakaran R.


The Drug regulatory authority of China was renewed from state pharmaceutical administration of China (SPAC) to state food and Drug administration (SFDA) with the announcement and declaration of Chinese ministry of health, the established regulatory standards of SFDA were keen to keep with international standards of EU, Japan and USA, the Drug registrations and Drug approvals are carried with established affiliated units for fast track evaluation within prescribed period ordered by SFDA, the state food and Drug administration is developed stringently and modified its standards according to the US healthcare regulatory system, in this review the permanently keeping standards of regulatory functions were detailed, and the untiring responsibilities of affiliated units of SFDA were to be recognized where their performance was a key aspect.

Keywords: SFDA, SPAC, EU, Japan, USFDA, ICH-CTD.


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How to Cite
Nadipineni, A. K., D. K. G., R. C. K., and S. R. “AN OVERVIEW OF CHINESE DRUG REGULATORY SYSTEM: A REVIEW”. International Journal of Drug Regulatory Affairs, Vol. 2, no. 3, Feb. 2018, pp. 14-18, doi:10.22270/ijdra.v2i3.137.

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