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      the procedure for Import Pharmaceutical Excipient Registration

    ADD DATE:2010-2-20 HITS:3

    In brief, if your products need not to be conducted clinical trials, and the Application Dossier are appropriate, you shall obtain IPEL within about 9 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 9 months after submission

    Step 2. Conducting the clinical trials.

    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 9 months after submission

     
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