CRED Getting the CMC Dossier Right 2024

28/08/2024

CEP Certificate of Suitability

• European Directorate for the Quality of Medicines (EDQM), a body of European Pharmacopoeia, assesses the drug substance and methods proposed for control for their suitability. May inspect manufacturers at company request. • CEP issued by EDQM and updated periodically on database – withdrawals, suspensions all publicly listed.

• Applicant files latest CEP to Health Authority

• CEP may not address all relevant parameters e.g no re-test period and thus applicant must supply drug substance stability data justifying proposed re-test period.

• European validity but may be accepted in other countries

CERTIFICATION OF SUBSTANCES FOR PHARMACEUTICAL USE - FAQs Home - FAQs (edqm.eu)

The Organisation for Professionals in Regulatory Affairs

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ASMF versus CEP

CEP

ASMF

• No further assessment in EU

• Assessed by each regulatory body

• a certificate of suitability is valid 5 years

Applicant responsible for co ordination

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• CEP renewed once, and then it is valid for an unlimited period, provided it is kept up to date by the holder.

• Frequent filing of updates required

May be used globally

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• Minimises additional routine testing

Valid for EU

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• Acceptable in some markets globally

The Organisation for Professionals in Regulatory Affairs

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