1. Background
1.1 Regulatory background
1.2 What is an NCI?
1.3 Who can apply?
1.4 Application status and analysis of all notified NCIs
2. Classification management and application procedure
2.1 Classification of NCI
2.2 Application procedure
3. Dossier requirements
3.1 NMPA filing account application
3.2 R&D report
3.3 Manufacturing process and quality control
3.4 Safety assessment report
4. Post notification/registration obligations
4.1 Monitoring period
4.2 Compliance suggestions
*The final outline may be subjected to subtle revision.