Open AccessAN OVERVIEW OF CHINESE DRUG REGULATORY SYSTEM: A REVIEW
Author(s) -
Ashok Kumar Nadipineni,
K G Dileep,
C K Ravindra,
R. Suthakaran
Publication year - 2018
Publication title -
international journal of drug regulatory affairs
Language(s) - English
Resource type - Journals
eISSN - 2321-7162
pISSN - 2321-6794
DOI - 10.22270/ijdra.v2i3.137
Subject(s) - food and drug administration , christian ministry , administration (probate law) , china , drug administration , regulatory affairs , business , public administration , political science , medicine , pharmacology , law , risk analysis (engineering)
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.