(EN) (PDF) – Assessment templates and guidance | European Medicines Agency


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This page lists the Committee for Medicinal Products for Human Use (CHMP) assessment report templates and documents used for the assessment of any new drug application in the centralised procedure.

The same templates should be used also for the Committee on Advanced Therapies (CAT) assessment report templates.

The documents provide general guidance on the evaluation of the quality, non-clinical and clinical aspects of new drug applications and extension applications.

Note to the CHMP, CAT and (Co)Rapporteurs: Assessment reports and comments should be circulated VIA EUDRALINK.

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via European Medicines Agency


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