Spécifications

eCTD Specifications

• TN-ANMPS eCTD Specifications and Guidance for Module 1 and Regional information -September 2024, v0.9. (for comment until 11/11/2024) [Link]

• TN-ANMPS CTD eSubmission Specifications - Sptember 2024, v0.9. (for comment until 11/11/2024) [Link]

• TN-ANMPS Validation criteria, v0.9 [Link]

• Feedback form [Link] ( email : This email address is being protected from spambots. You need JavaScript enabled to view it. )

• TN-ANMPS eCTD Q&A v1.01 [Link] 

Technical Files

• ANMPS Util folder (DTD and Style Sheets) for Module 1. [Link]

• Samples 
  
  • Comprehensive eSubmission Element Sample

• Defined Lists & Validation Matrices
  • application-type.xml
  • contact-type.xml
  • document-matrix.xml
  • evaluation-path.xml
  • sequence-type.xml
  • submission-type-matrix.xml
  • submission-lead.xml
  • submission-type.xml

eCTD System Sample URS

• ANMPS eCTD System-Sample User Requirement Specifications (URS). [Link]