On December 15, 2015, the International Conference on Harmonization (ICH) endorsed Step 4 of the eCTD v4.0 Implementation Package v1.0. Step 4 signals that major stakeholders agree on guidance. ICH released its implementation guide in early April 2016 and regulators in the US and EU followed suit. Industry is taking very real steps to implement eCTD v4. I’ve compiled a list of expectations on timing and impact for eCTD v4.
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 Australian Therapeutic Goods Administration (TGA) appears ready to proceed with a pilot program that will pave the way for full adoption of eCTD submissions.
Compound documents will not be part of the Regulated Product Submissions (RPS) standard. The decision was recently announced by the International Conference on Harmonisation’s (ICH) M8 working group which had been deliberating on a number of negative ballot comments registered in September 2013.
The requirement to submit certain drug applications in electronic format is at least three years off, and the target date for the implementation of the new Module 1 has been extended yet again according to representatives of the U.S. Food & Drug Administration.