Preparing a drug registration for the US and the EU:

Parallel or sequential applications? – Part 1

Nathalie Boeglin, Alice Rolland, Frederic Pailloux and David Uguen

Published in Regulatory Rapporteur, Vol 12, n°2, February 2015

CONTENTS

01 Introduction 3

02 Regulatory planning 4

03 Voisin Consulting Life Sciences 5

04 Additional information 6

Introduction

FDA and EMA: an overview of the main challenges faced by applicants for the conversion of their dossier from one agency to the other.

Pharmaceutical companies (also referred to as ‘sponsors’ or ‘applicants’) involved in global drug development usually aim to submit marketing authorisation applications to both the US FDA and the European Medicines Agency (EMA). The ability to file the same information to both the FDA and the EMA with little or no delay between the two applications has been significantly improved by the International Conference on Harmonisation (ICH) process and the development of the Common Technical Document (CTD) format which can now be used equally in the two regions.

Due to obvious time and budget constraints, applicants are now considering the preparation of one global regulatory strategy and ideally one single core application which needs minimal adaptation to meet both US and EU requirements. To do so, sponsors may adopt the “parallel approach”, where one core dossier is developed and geographical/regional considerations are included and highlighted during preparation of the dossier to allow the simultaneous completion and submission of the applications in both regions. They may alternatively choose the “sequential approach”, where the application is prepared for the first region of interest (and submitted in that region first) and then adapted/converted to meet the requirements of the other region (and submitted there subsequently).

Regulatory strategy

Objective: CMC focusThe purpose of this paper is not to provide an exhaustive list of differences in the Module 3 between the two regions, but to point out the critical items for consideration when converting an NDA/BLA into an MAA and vice versa.

Main differences US/EUAs far as the Quality documentation of the drug registration applications is concerned, the main differences between the US and the EU regions are directly linked to the different levels of detail generally required for each section of the application due to the different review processes in the two regions.

Policy maker’s perspectiveThe Quality documentation is compiled from early stages of the clinical development as the CTD format also applies to the investigational medicinal product dossier (IMPD) of the EU CTAs and to the Module 3 of the US IND applications. Thus sponsors undertaking a global drug development programme would generally favour the parallel approach for the preparation of the Quality Modules of the CTD for registration applications, given that they have to prepare the Quality sections of IMPD and IND at the same time for the two regions.

The CTD content is driven by ICH guidelines for Quality (Q, also known as CMC in the US), Efficacy (E, clinical) and Safety (S, nonclinical), and is almost equally applicable in the US and the EU.

The regulatory strategy should include decision-making criteria and planning for parallel or sequential preparation and submission of the MAAs. Both are possible, as the Common Technical Document (CTD) format, which is used for the presentation of the data, is common – for the most part – to both regions.

Voisin Consulting Life Sciences

Cambridge, MA, San Francisco, CA & Somerville, NJ, USA London, UK Paris & Rennes, France Lausanne, Switzerland Bangalore, India

Founded in 1997 by Dr. Emmanuelle M. Voisin, VCLS is a team of over 100 life science professionals located in the US, Europe and Asia.

VCLS supports Biotech, Pharma and Medtech manufacturers to:• Design global product development

strategies• Engage with local regulators & payers

We believe that product development must be driven by a solid understanding of the environment within which the product will be launched, and the criteria by which elements of the development will be assessed by both regulators and payers.

VCLS partners with life science companies across European, North American and international markets.

For more information

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Nathalie Boeglin, Pharm. D, Ph. D., is a Director at VCLS, specialized in registration procedures, notably in Europe. She has over 10 years of experience in the pharmaceutical industry and 6 as a regulatory

consultant, leading over 20 successful MAA submissions. Learn more about her

VoisinConsulting.com