• Last updated：2024-08-30
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Since its establishment, the CDE has continually improved in the technical review of pharmaceuticals. As a crucial government ally, the CDE's scope has expanded to include technical review for drugs, medical devices, health foods, and special nutritional products. It also conducts review on cell therapy technology projects and health technology assessment, offering consultation services in these areas. Additionally, it assists in drafting guidelines and regulations for the government.

The CDE is committed to spreading its accumulated expertise in regulatory science and health technology assessment through various educational activities such as workshops, expert training sessions, university lectures, and student internships. It aims to cultivate domestic talent and actively participates in international conferences and events, facilitating exchanges with regulatory authorities and international organizations in health technology assessment. This engagement ensures it stays abreast of global trends, promoting regional regulatory harmonization and international cooperation.

Major Tasks

• Review on Technical Documents of Medicinal Products
  
  • Review on Clinical Trial Protocol of Investigational New Drug (IND) Application
  • Review on New Drugs (NDA) and Related Extension and Post-approval Change Application
  • Review on Generics (ANDA) and Related Extension and Post-approval Change Application
  • Review on Bridging Study Evaluation (BSE) Application
  • Review on Drug Substance (API) / Drug Master File (DMF) Application
  • Review on Dissolution Profile Comparison / Bioavailability (BA) / Bioequivalence (BE) study report 
  • Review on Over-the-Counter (OTC) Drug Application
• Review on Cell Therapy Technology Projects
• Review on Technical Documents of Medical Devices
  
  • Review on Clinical Trial Protocol of Medical Devices
  • Review on Clinical Study Report of Medical Devices
  • Review on Pre-Market Approvals of Medical Devices
  • Review on Special Import Application of Medical Devices
• Review on Health Food and Special Dietary Food
• Health Technology Assessment (HTA)
  
  • Establishment and Updating of Guidelines for Health Technology Assessments
  • Health Technology Assessment for Reimbursement of New Drugs and Medical Devices
  • Healthcare Technology Assessment for Health and Welfare Policy
  • Research on Health Technology Assessment
  • Research on Health Technology Reassessment
• Consultation Services
  
  • General Regulatory Consultation Services
  • Consultation Services for Cases under Review
  • Consultation Services on Index Case
  • Paid Consultation
• Drafting guidelines and regulations
• Conduct seminars, lectures, educational training, and industry-government-academic communication meetings