Electronic Common Technical Document Technical Conformance Guide

Technical conformance guides traditionally have been used to provide operational guidance on "how to submit" and have not provided substantive information on policy changes to the content of submissions. PDA believes this technical conformance guide has important new content expectations that will have a significant impact on industry, primarily those involved in combination product submissions. As such, PDA strongly believes that these expectations should have been issued in a Type 1 draft policy guidance. PDA also has concerns about the recommended content and placement of combination product information as specified in this eCTD conformance guide. These new requirements will result in a document that is no longer a common document for drug delivery products in all the regions that accept the ICH CTD format. This puts FDA out of alignment with other ICH regions and impacts license holders as multiple versions of the quality module will need to be maintained for global products.