Folder Element Type Attributes

You can enter values for additional eCTD attributes in the following ICH eCTD M2-5 folders:

• 2.3.S Drug Substance - Substance, Manufacturer
• 2.3.P Drug Product - Product Name, Manufacturer, Dosage Form
• 2.7.3 Summary of Clinical Efficacy - Indication
• 3.2.S Drug Substance - Substance, Manufacturer
• 3.2.P Drug Product - Product Name, Manufacturer, Dosage Form
• 3.2.P.4 Excipients - Excipient Name
• 3.2.A.1 Facilities and Equipment - Manufacturer, Substance, Dosage Form, Product Name
• 3.2.A.2 Adventitious Agents - Manufacturer, Substance, Dosage Form, Product Name
• 5.3.5 Reports of Efficacy and Safety Studies - Indication