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The procedure for Import Pharmaceutical Excipient CFDA Registration

 

In brief, each Pharmaceutical excipient company wants to market Pharm products in China, must apply CFDA registration, obtain IPEL (import pharmaceutical excipient license) before marketing. The foreign Pharmaceutical excipient companies can?ˉt submit application to CFDA directly, they must appoint a registration Legal Agent in china to do this job.

If your Pharmaceutical excipient product is Generic excipient, need not to be conducted clinical trials (some need Bio-equivalence trials), and the Application Dossier are appropriate, you shall obtain IPEL (import pharmaceutical excipient license) in 18-24 months

If belong to New Pharmaceutical excipient, clinical trials must be conducted, you shall obtain IPEL within about 3~4 year.

The New Pharm excipient products CFDA registration 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 IPEL 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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