CRED 8 Presentations

01/07/2024

How CTD (common technical document) modules are organised

The Organisation for Professionals in Regulatory Affairs

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The ICH Common Technical Document (“CTD”) specifies that Module 1 should contain region-specific administrative and product information . The following items listed in the Notice to Applicants are included in an initial submission in EU eCTD as follows: 1.0 Cover letter 1.1 Comprehensive table of contents (in eCTD the XML backbone acts as a table of contents) 1.2 Application form 1.3 Product information documents 1.4 Information on the experts 1.5 Specific requirements for different types of applications (if required) 1.6 Environmental risk assessment 1.7 Information relating to orphan market exclusivity (if required) 1.8 Information relating to pharmacovigilance 1.9 Information relating to clinical trials (if required) 1.10 Information relating to paediatrics. For eCTD the Module 1 should also include a tracking table. Module 1: Regional Information

The Organisation for Professionals in Regulatory Affairs

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