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...

Read More
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 The previous priority levels of A, B, and C have been removed, and have been replaced by Pass, Fail, and Best Practice.

Read More

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.

Read More

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...

Read More

An Aggregation of Recent eCTD News, Part II

As promised, here is an expanded list of posts published recently on my twitter account, this time related to agency news: CMD(h) issued a new Best Practice Guide on the use of eCTD in the MRP/DCP. Dr Martin Moxham of iRegulatory provided an excellent review of the updated CMDh best practice guide. CMDh also posted Contact E-Mail Addresses For Submission Of Electronic Response Documents During Mutual Recognition & Decentralised...

Read More