CRED Getting the CMC Dossier Right 2018

03/05/2018

Chemistry, Manufacturing & Controls (CMC)

Learning Objectives

Introduction to Preparing the Perfect Common Technical

• Origin of the Common Technical Document (CTD) • Overview of CTD structure - where drug substance data fits (Module 3.2.S) • Different routes to incorporate drug substance data into 3.2.S: originator data, ASMF (or DMF) or CEP • Overview of variations in the EU • Due-Diligence Tips

Document (CTD) Module 3 Part ‘S’

21 May 2018

Christopher Carr, Global BD Lead, ERA Consulting Christopher.carr@eraconsulting.com

ENABLINGANDPROMOTINGEXCELLENCE INTHEHEALTHCAREREGULATORYPROFESSION

Some Common Abbreviations

What is regulated?

ASM

Active Substance Manufacturer Active Substance Master File

• Clinical Research

ASMF

CEP

Certificate of Suitability to the monograph of the European Pharmacopoeia

• Marketing Authorisations

CTD

Common Technical Document

• Compliance with Standards (GXP) • Manufacturing • Advertising and promotion • Pharmacovigilance

DS

Drug Substance

(E)DMF

(European) Drug Master File (syn. for ASMF)

EDQM

European Directorate for the Quality of Medicines

eCTD

Electronic Common Technical Document International Conference on Harmonisation

ICH

NCE

New Chemical Entity

Why are there Regulations?

Brief History of Regulations...

Historically, regulation has been introduced as reactions to events such as the European Thalidomide tragedy causing birth defects and the Elixir Sulphanilamide disaster which killed over 100 people in the US 1906 - Public Pressure in the USA lead to the Pure Food and Drug act which prevents interstate trade in adulterated food, drugs and drinks 1910 - Introduction of arsphenamine (anti syphilitic organic arsenical) let to the UK Therapeutic Substances Act 1927 - Introduction of Elixir Sulfanilamide in the USA led to the USA Food, Drug and Cosmetic Act (1938) 1957 - Introduction of Thalidomide in Led to a number of new Laws: ● USA Kefauver-Harris Drug Amendments (1962) ● UK Committee on Safety Drug (1963) ● UK Medicines Act (1968) Today Advancing scientific Knowledge is the key driver for legislation changes and increasing R&D costs

Government must decide whether the benefit to the population is commensurate with the

Patients and Prescribers must have access to safe and effective medicines

potential risk and increasingly cost

Is the potential risk to the patient outweighed by the

Industry and academia must have a clear understanding of what is required

potential benefit??

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