Australia Set for eCTD Submissions Pilot Program
Jul01

Australia Set for eCTD Submissions Pilot Program

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.

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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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Analysis of New, Draft TGA (Australia) M1 CTD Guidance (Part 2)

My last analysis of the new TGA (Australia) Draft Module 1 Administrative Information and Prescribing Information left off at section 1.5.5 before analysis paralysis set in… today I wrap up with an examination of the rest of the document. In Section 1.6.1 Relevant external sources, as in most sections, example forms have been replaced with instructions to download forms from the TGA website. In this case, each referenced DMF,...

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Analysis of New, Draft TGA (Australia) M1 CTD Guidance

I sat down to take a look at the new TGA (Australia) Draft Module 1 Administrative Information and Prescribing Information. This is a whopper of a document (96 pages), carefully written to provide a wealth of additional information to sponsors. The document contains a number of major and minor changes, and has been re-formatted to make extensive use of bullet lists for greater clarity. The new guidance addresses subsequent data...

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Collection of eCTD Online News, Part 1

Today’s post is a round-up of recent eSubmission-related news from the agencies, based on posts from my twitter account, www.twitter.com/kathie_clark. Next time, a roundup of articles and conferences. The regulatory authorities haven’t put out much in the way of major updates recently, but there have been some updates worth noting: ICH issued a new valid-values.xml for study tagging files see my Blog Post on The eCTD Summit for...

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