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SFDA boosts the supervision and implementation of GMP



The State Food and Drug Administration (SFDA) issued a notice on October 26, 2004 to raise specific requirements on the supervision and implementation of GMP in  prepared slices of Chinese crude drugs, medical gases and biological in vitro diagnostic reagents.
                                                
As of January 1, 2006, all biological in vitro diagnostic reagents administrated as drugs must be produced subject to GMP requirements; as of January 1, 2007, all medical gases must be produced subject to GMP requirements; and as of January 1, 2008, all prepared slices of Chinese crude drugs must be produced subject to GMP requirements. Manufacturers of the mentioned products that have not met the requirements of GMP and obtained the GMP Certificate within the stipulated time will be suspended from operation.

When applying for the approval and issuance of GMP Certificate for prepared slices of Chinese crude drugs by authority, the scope of inspection shall be indicated, such as containing toxic prepared slices of Chinese crude drugs, containing prepared slices of Chinese crude drugs for direct-taking and the corresponding processing methods (such as cleaning, cutting, stir-frying, calcining, steaming).

SFDA also issued the review standards for prepared slices of Chinese crude drugs and medical gases.