Saturday, January 9, 2010

The Difference between TGA and EU CTD Filings

A client of mine just asked me several days ago, a drug was purchased from a company that was in distress, the "price was right". The drug was just approved in the EU. The client wanted to submit the same CTD dossier to TGA (Australia).

The client is correct on one hand and needs advice on the other. In my experience to handle sections with "identical" content for TGA, EU, FDA, others - consider first that nothing is a cut and paste, nothing is identical, nothing is exactly the same from one submission to another. Second, to save time, map similar sections from one document to another, perform a cut and paste activity from one document to another and modify as needed. A QC must be performed to deem this documentation QC final and QA certified.

The answer to the larger question - yes, TGA is happy to use the CTD documentation from EU for their review, however, there are certain sections that must be, by requirement expanded. One of these sections is clinical laboratory data, ECG and otherwise. Another difference between EU and TGA, is "narratives" - narratives (several types) may be included in Module 1 for TGA, not so with EU. So, here are two examples, the former pertaining to expansion of data and the latter pertaining to a change in content location. The point, whether minor and major - there are differences.

Communication with TGA is a must to understand fully the target TOC, the arrangement and the exact organization for the format and the entire clinical submission. Always request correspondence, minutes to the meeting, TC or face to face - this information becomes critical at the time of filing and RTF and completeness. QC the clinical submission - all Modules - for accuracy and consistency across all data and documents.

No comments:

Post a Comment