Spring Intro 2023

28/03/2023

Drug Substance Modalities

Small molecule

Monoclonal antibodies Complex biologics Cell & Gene Therapy

“Class of 2016”. Innovative therapies with a 2016 action date filed with FDA, n=35

The Organisation for Professionals in Regulatory Affairs

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Common Technical Document (CTD)

Module 1 Regional Administrative Information 1.0

CMC is responsible for Module 1 (regional administrative information), Module 2.3 and Module 3

CTD Table of Contents 2.1

CTD Introduction 2.2

Clinical Summary 2.7 Clinical Overview 2.5

Non-clinical Overview 2.4

Module 2

Quality Overall Summary 2.3

Non-clinical Written and Tabulated Summaries 2.6

Module 5 Clinical Study Reports 5.0

Module 3 Quality 3.0

Module 4 Nonclinical Study Reports 4.0

The Organisation for Professionals in Regulatory Affairs

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