Final Health Canada eCTD Guidance Addresses Naming Conventions, Lifecycle Operations

Health Canada has posted a final version of Guidance for Industry: Preparation of Drug Submissions in Electronic Common Technical Document (eCTD) Format on their web site. This version, dated November 4, 2009, replaces the draft version dated January 25, 2006. On the whole, the changes are more evolutionary than revolutionary. Throughout the document, the previous terminology of “Annual update forms summarizing the Notices of Change”...

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Preparing for the FDA’s eCTD Mandate

Editor’s Note: Our first session is completely full. We have added a second session on December 8th at 11 AM EST. Please follow the link below to register: http://www.eventbrite.com/event/474671756 Don’t have time to keep up-to-date on eCTD regulations and guidance around the world? Wondering when eCTD will become mandatory, (or even accepted), in a given market? Join GlobalSubmit and Cato Research on Thursday, November 5th at 2...

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RPS Working Group Reviews ICH Requirements

The RPS (Regulated Product Submissions) Working Group met last week in Atlanta. The main discussion points were around ICH requirements, multi product submission, facility submissions, linking to other applications, multi regulator submission and how should the project be managed going forward. All current ICH requirements were reviewed. Most of the requirements are already met. Some more requirements need to be addressed. I expect...

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EMEA Electronic Application Forms, Swissmedic M1 Specification

EMEA has released new versions of their electronic Application Forms (eAF) as part of Volume 2B – Presentation and content of the dossier. All three forms (for new applications, variations and renewals) have been posted. Updates are due to changes in the Data Exchange Standard Definitions released July 2009. Changes are significant, so if you have done any custom development around the eAF, you will need to make a number of updates....

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What’s Included in the New EU Module 1 Specification v1.4?

As promised, the EMEA released Version 1.4 of the EU Module 1 Specification on schedule in August. The new spec has some changes that will impact eCTD assembly, publishing, verification and viewing software tools. The EMEA has reached out to the vendor community to ensure that they are aware of the changes to ensure that they can modify their products in advance of the required implementation timeline. It’s worth reproducing that...

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