• Last updated：2024-08-13
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The Center for Drug Evaluation (CDE), with its extensive knowledge of domestic and international regulatory science and many years of review experience, provides consultation services for companies and R&D units at all stages of drug development.

Consultation Services for Drugs:

1. Research and Development Stage:
   • Clinical Trial Consultation
   • Regulatory strategy consultation
   • General regulatory consultation
   • Index case consultation
2. Pre-Submission Stage (Technical Dossier Completed):
   • IND prior assessment
   • Pre-ANDA Meeting
   • Module-Based Rolling Review
3. In the Review Stage:
   • Review related consultation (RRC)
4. Appeal & Re-submission Stage
5. Post-Approval Requirements