• Last updated：2024-12-31
• Count Views：1342

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:

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