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SFDA May Close Substandard Drug Firms

Some 2,000 drug producing companies will be closed as they would certainly fail to pass the Good Manufacturing Practice (GMP) authentication by July 1, said an official from the State Food and Drug Administration (SFDA).

 

Latest statistics show that more than 2,800 drug manufacturer out of 6,000 have passed the GMP authentication so far, leaving some 1,000 in the procedure of technology upgrading and another 2,000 which would certainly fail.

 

"Medicine producers which fail to pass the authentication will be closed down," said Bai Huiliang, director in charge of safety supervision department under the SFDA at a seminar on China's Medicine and Health Production held recently.

 

To those companies in the technology upgrading, the SFDA will give six months of grace period. By the end of this year, if they still couldn't pass, they will be closed down.

 

China introduced in the GMP authentication, an international standards of medicine production, in 1998. In 2003, as a measure to ensure medicine safety, the SFDA regulated compulsively that all drug enterprises and workshops would have to pass the GMP authentication since July 1, 2004 to continue operation.

 

Bai noted that the adoption of GMP has helped promote the structure and production upgrading of the medicine industries. In 1998, only 87 medicine manufacturers passed the GMP inspections. Now producers of all blood products, injections and powder injections have all passed the GMP authentication. The rate of qualified medicine reached 97 percent in the survey in 2003 from 89 percent five years ago.

 

(Xinhua News Agency May 8, 2004)

 

GMP Standards Should Be Better Followed
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