Comparing EMA and Health Canada CTA Submission for Phase I Trials to US FDA IND Application

March 9 2021

Kent , United Kingdom

Foreign clinical trial data is accepted under US Food and Drug Administration (FDA) regulations to support New Drug Application (NDA) (including 505 (b)(2)) and Abbreviated NDA (ANDA) submissions.

It is a common assumption that pharma and biotech companies are focused on these regulatory submissions to the US FDA. In fact, US-based contract research organisations often provide what they refer to as their “standard Investigational New Drug (IND)-enabling programme” when initiating discussions with new clients. However, for a variety of reasons, the drug development strategy of many companies is to conduct first-in-human (FIH) clinical studies outside of the US.

To ensure the safety of Phase I healthy trial subjects, the generation and conduct of suitable non-clinical toxicology studies is documented in the international harmonised guidance ICH M3 R2. However, the presentation of this data as a well-argued case, conforming to local regulatory expectations and standards, is key to a successful foreign regulatory authority submission.

This webinar will provide an overview of a foreign health authority’s requirements for gaining approval to conduct an FIH clinical trial by comparing Health Canada and European Medicines Agency (EMA) Clinical Trial Authorisation (CTA) processes to that of the FDA IND submission. The presentation will cover the following:

Highlight similarities and differences
Provide an overview of the receiving divisions
Summarise each regulatory agency’s review process, submission process and content
Review timelines for CTA/IND submissions.

Speakers

@PharmaReview

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