Many international regulatory affairs professionals have come to dread the phrase “Module 1 Change” in the past decade. What looks like a simple reshuffling of leaf titles or the addition of a few new submission types grows into a much more complex problem to solve. Those of you in regulatory operations see on thing in large red letters – VALIDATION. The European Union is taking its turn in 2016. The EU M1 v3.0 final specification was published in October 2015 and is set to take effect July 1, 2016. The specifications become mandatory on October 1, 2016.
The U.S. FDA and Health Canada have each updated their submission requirements for Drug Master Files (DMFs). Understanding each agency’s requirements will be critical to compliance in the coming months as eCTD mandates go into effect.
The current FDA specifications governing grouped submissions state that Application Type and Submission Type have to agree. Accordingly, you would have no trouble grouping NDA labeling supplements.
A grouped submission eliminates the need to submit multiple, identical submissions to different applications. For example, a manufacturing part change might impact a dozen applications. In the age of grouped submissions, a new sequence would be created to note the part change, and that sequence would then point to all other applications affected.
A number of sponsors have recently inquired as to the proper use of the modified-file attributes (operators) when using Study Tagging Files (STFs). Our research has yielded a number of helpful findings on the subject.
The Lifecycle Management section (page 10) of the latest ICH guidance on eCTD Backbone Files Specification for Study Tagging Files incorrectly states that the modified-file attribute of “append” is used to control lifecycle operations of that STF. While the documentation is wrong we don’t expect a timely update.