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China – SFDA Requirement For Generic Pharmaceutical Re-Evaluation.

5 December, 2012

 

Legal News & Analysis – Asia Pacific – China – Regulatory & Compliance

 

China has become the world’s largest market for generic pharmaceuticals. Generics account for more than 90% of China’s total pharmaceutical market.
 
Following the release earlier this year by the State Council of its “12th 5-year Plan for Drug Safety” (“Drug Safety Plan”), on 22 November 2012 the State Food and Drug Administration (“SFDA”) issued a discussion paper entitled “Work Plan for the Evaluation of the Quality Consistency of Generics” (“Generics Quality Plan”). 
 
The Generics Quality Plan seeks to canvass opinion as to how, and under what timetable, SFDA should implement one of the key policies outlined in the Drug Safety Plan, namely that:
 
any China–manufactured generic pharmaceutical product, registered in China before October 2007 (“Pre-07 Generic”), must be re-tested and re-evaluated (“ReEvaluation”) for its registration to remain valid.

  

For a diagram of the proposed Re-Evaluation Plan, please click here.

 

 
For further information, please contact:
 
Brinton M. Scott, Partner, Clyde & Co
 
David Wyatt, Partner, Clyde & Co

 

 

 

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