CRED Getting the CMC Dossier Right 2024

28/08/2024

Some Common Abbreviations

ASM

Active Substance Manufacturer

ASMF

Active Substance Master File

CEP

Certificate of Suitability to the monograph of the European Pharmacopoeia

CTD

Common Technical Document

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

ICH

International Conference on Harmonisation

NCE

New Chemical Entity

The Organisation for Professionals in Regulatory Affairs

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Why are there Regulations?

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 potential benefit??

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

The Organisation for Professionals in Regulatory Affairs

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