Approval for new drug registration more strict

   Date:2007/07/11     Source:
The director of drug registration management division of China's State Food and Drug Administration, Zhang Wei said, "from the beginning of the sepcial action of rectifying and regulating the food and drug market the second half of last year, SFDA and relevant administrations have strengthened on site examination in the process of examination and approval for new drug application, and the application which can't meet the requirements would be withdrawed by relevant enterprises.

In the past over one year, pharmaceutical enterprises totally withdrawed 6441 drug registration applications, over 20% of all registration applications. 578 approval number were cancelled. SFDA denyed to approve 1437 registration applications because which can't meet the requirements.

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