Medical Writing Generics and biosimilars Regulatory pathways for development and submission activities
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Volume 28, Issue 2 - Generics and biosimilars

Regulatory pathways for development and submission activities

Abstract

This article discusses how different regulatory requirements for a dossier requesting marketing authorisation for a medical drug affect the deliverables from development functions and the submission groups including medical writing. The content of the dossier submitted is strongly interlinked to the legal basis selected for a regulatory filing. This drives the requirements of data from different areas of development as well as of dossiers that can be summarised mainly into the general categories of Chemistry, Manufacturing and Controls (Common Technical Document (CTD) dossier Module 3), non-clinical (CTD dossier Module 4), and clinical (CTD dossier Module 5) reports. This article addresses different types of regulatory pathways in the EU and the US with case examples where possible. The pathways used in the generic and biosimilar industries are discussed regarding expectations of authorities in an application type. Although this article focuses on clinical research and clinical data requirements within the generic and biosimilar industries, it also addresses how other parts of the dossiers are affected.

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Articles

Introduction
James Visanji Tribute
President’s Message
EMWA News
Regulatory pathways for development and submission activities
Biosimilar development – an overview
Statistical principles in biosimilar development
Writing biosimilar clinical study reports and submission documents – what to expect and what to consider
Medical writing for generics throughout the life cycle
Same but different: Basic tools for biosimilar and generic pharmacovigilance writing
Layperson materials in the sphere of biosimilars and generic medicines
Insulin biosimilars
Biosimilars: Change, challenge, and accomplishments
ICMJE requirements for sharing individual participant data from interventional clinical trials
Medicinal products and medical devices in clinical trials conduct and disclosure
Publication of clinical trial protocols and statistical analysis plans on ClinicalTrials.gov
Collecting metrics in medical writing – the benefits to you and your business
Document management systems for medical writing
Winner of the Geoff Hall Scholarship Essay Competition
Regulatory Matters
News from the EMA
Getting Your Foot in the Door
Veterinary Medical Writing
Teaching Medical Writing
Medical Devices
My First Medical Writing
Journal Watch
Good Writing Practice
Regulatory Public Disclosure
Out on Our Own

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