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The procedure for Import Drug SFDA Registration

 

In brief, if your products need not to be conducted clinical trials, and the Application Dossier are appropriate, you shall obtain IDL within about 9-12 months after submission. If clinical trials must be conducted, the general procedure is:

Step 1. Submitting an application and if the Application Dossier are appropriate, you shall obtain Clinical Trials Permission (CTP) within about 10-12 months after submission

Step 2.   Conducting the clinical trials, if just carry out bioequivalence trials, it might be take 3 to 6 months, but other clinical trials might be take more than 1-1.5 year to complete.

Step 3.  Submitting the Application Dossier (include the reports of clinical trials) and if the Application Dossier are appropriate, you shall obtain IDL within about 12-18 months after submission Please contact us for details about this and for more information including, we shall send the further information and our quotation to you after receive the introduction of your products.

 

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