Regulatory Focus™ > News Articles > China Sets Deadlines for Drug GMP Implementation

China Sets Deadlines for Drug GMP Implementation

Posted 14 January 2013 | By Ansis Helmanis

China's State Food and Drug Administration (SFDA), the National Development and Reform Commission, the Ministry of Industry and Information Technology, and the Ministry of Health issued on 21 December 2012, a joint notice to the provinces and municipalities setting forth deadlines for implementation of the revised good manufacturing practices (GMPs) by the pharmaceutical industry. 

Injectable drug manufacturers must implement the revised GMPs by 1 January 2014, and the manufacturers of other drugs must do so by 1 January 2016.  The notice also recommends that authorities responsible for setting drug prices should consider the cost of GMP compliance when making product-pricing decisions.


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