Preparing a Drug Registration for the US and the EU Parallel or sequential applications – Part 2

Published on: Jun 8, 2015

This article, the second in a two part paper highlights the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region to another, and deciding between a sequential and a parallel preparation.

June 2015 – Regulatory Rapporteur

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Preparing a Drug Registration for the US and the EU Parallel or sequential applications – Part 2

PUBLICATION BY

FRÉDÉRIC PAILLOUX, PHARM.D., M.SC.

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