CRED Getting the CMC Dossier Right 2024

28/08/2024

How are Monographs Developed?

Initiation

Development

Publication

Revision

Omission

High product volumes

Data from MAHs, compendia and literature

Revision request

EAG agreement

No UK MAHs

Clinical need

Data from compendia MAHs & literature

Secretariat review

No longer in widespread use

Drug substance monograph pre-requisite

EAG review

BPC: DRT review

BPC: endorse omission of monographs

Lab assessment

EAG review

BPC: endorse addition to work programme

Establish BPCRS

Lab assessment

BPC: input as EAG members

Establish BPCRS

BPC: input as EAG members

BPC: policy & procedure

BPC: policy & procedure

The Organisation for Professionals in Regulatory Affairs

53

How are Monographs Developed?

The Organisation for Professionals in Regulatory Affairs

54

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