AN OVERVIEW OF CHINESE DRUG REGULATORY SYSTEM: A REVIEW

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

Abstract

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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References

1. Department of State Food and Drug Administration (SFDA) Guidelines on data required for approval for marketing a new Drug [Internet]. 2014 [cited, 2014 Jan] Available from:
http://www.sfdaChina.com/info/80-1.htm
2. William J B, Kenneth L, Hastings, Kathy M. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations. McGown John Wiley & Sons; 2013.
3. Wikipedia, the free encyclopedia. [Internet]. 2013 [cited, 2014 Jan] Available from: http://en.wikipedia.org/wiki/Pharmacopoeia of the People's Republic of China.
4. Tiger med news, [Internet]. 2014 [cited, 2014 Jan] Available from:
http://www.tigermed.net/newsinfozz.php?newid=131
5. China CFDA (SFDA) regulations [Internet]. 2014 [cited, 2014 May]. Available from: http://www.sfdaChina.com/.
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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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