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Enter the new GMP certification will not change the countdown time, said CFDA

Update:2013-7-30 16:07:40   From::本站   Editer:admin   

According to Voice of China "news and newspaper summary" report, at present, more than 1,300 sterile pharmaceutical production enterprises, has passed the new version of "Good Manufacturing Practice", which is "GMP" certification is only two percent. State Food and Drug Administration recently said that December 31 will be the "deadline."

According to the new GMP, blood products, vaccines, injections of sterile medicinal products, should be reached before the end of the year the new regulatory requirements; 5 months after the deadline is approaching, the State Food and Drug Administration Drug Administration Division is responsible for people Guoqing expressly time table does not move.

Li Guoqing: Standard determined not to reduce the time and never relaxed, hoping enterprises should attach great importance to this work, do not misjudge the situation and to find someone to intercede when there is no use crying to no avail.

State functions change the claim relating to certification authority delegated with pharmaceutical companies which would like to see GMP certification to the provinces, and to relax standards. Li Guoqing position, only until after the completion of the current round of certification authority delegated to consider the problem;

Li Guoqing: December 31, 2013 did not pass the certification, to January 1, 2014 must be discontinued, you can follow through certification. Fresh Drug Administration as this one is firm in terms.

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