Tag Archives: Health Canada

International Trends in Drug Registration and Evaluation [Part 2: eCTD v4.0]

Our last blog post on this topic covered eCTD v3.2.2 and its advantages over paper or non-eCTD electronic submissions. The main selling points of v3.2.2 are its reliable presentation of information to reviewers, the level of flexibility for national authorities, the metadata for automated processing, the life cycle information on documents, and the reuse of information.

Introduction
In this second part of our series about international trends in drug registration we dive into the improvements from eCTD v4.0 over eCTD v3.2.2.

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The NDA Marriage – Complementing Regulatory Strategies with Technical Solutions

Jillian Lee

The presentation “The NDA Marriage” was given by Jillian Lee, Senior Global Submission Specialist at Bayer Health Care AG, at LORENZ userBridge.14 in Milan, Italy.

In her presentation, Jillian Lee outlined an approach for concurrent submission applications.

Background: sequential regulatory requirements
Bayer’s mission is “Science For A Better Life”. For the pharmaceuticals division, this means – making available safe, effective, and potential life-saving options to patients as quickly as possible. Currently however, technical barriers prevent the submission of a NEW indication for a drug while the first indication is still in the initial approval process with health agencies.

So a solution is needed to reduce the overall review timelines and potentially help in “fast-tracking” approvals. The answer is simple, although technically complex: enable concurrent applications. Continue reading