What You Need to Know about Europe’s eCTD Module 1 v3.0 Specification
Feb18

What You Need to Know about Europe’s eCTD Module 1 v3.0 Specification

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.

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Simultaneous eCTD Submissions to Multiple Regions

Traditionally, a pharmaceutical company would seek to have a drug approved in one region, and then move to other regions around the world to seek approval. Typically, companies would seek approval in their country of origin, then pursue the biggest markets, and finally focus on the rest of the world. The advent of CTD provided a common organizational structure to create submissions around the world. The ability to reuse large parts of...

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Pass, Fail, Best Practice Introduced into EU eCTD Validation Criteria
Jul18

Pass, Fail, Best Practice Introduced into EU eCTD Validation Criteria

The European region is going to put new validation criteria into effect in September 2011. The previous priority levels of A, B, and C have been removed, and have been replaced by Pass, Fail, and Best Practice.

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Next RPS Ballot Delayed Until September 2011

The May 2011 ballot date was missed and is now delayed until September 2011. Why was the date missed? In my opinion, we are still working on refining all of the requirements. We have two requirements left to be finalized; namely, being able to reuse studies and all of the components in two applications and support for the new European variation legislation.

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FDA eCTD Review Process Q&A

Earlier this week, GlobalSubmit and Cato Research held an educational webinar on the FDA eCTD Review Process. The purpose of the webinar was to provide an overview of the various steps and stages that a drug application goes through in order to be approved by the FDA and marketed in the United States. During the webinar, GlobalSubmit’s CTO Jason Rock discussed the FDA’s workflow, the challenges they face in the electronic...

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