CRED Getting the CMC Dossier Right 2024

29/08/2024

In this presentation we will cover:

• Principles of assessment

• The drug substance dossier

• New Chemical Entities vs Known Active Substances

Types of Submissions

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• Quality Overall Summary

GMP & Inspections

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• Falsified Medicines Legislation

• Drug substances and Brexit

• Some common deficiencies

Hints & tips

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The Organisation for Professionals in Regulatory Affairs

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MHRA

• SR&I : NIBSC, CTU, Innovation office/EAMS

• HQA : Licensing (now split into Innovative medicines and Population health), BP, Inspectorate, Devices, IPU (now DAQ [Data Assurance & Quality] within Authorisation lifecycle)

• S&S : VRMM (PhV & RMP), CPRD, DMRC

Partnerships : Policy

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• Corporate services : includes Finance

Contact MHRA - GOV.UK (www.gov.uk)

The Organisation for Professionals in Regulatory Affairs

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