Assessment templates and guidance

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.

It is strongly advised that assessors have the Agency's styles installed in Microsoft Word to ensure an optimal use of the templates. For support, please use the online EMA Service Desk portal.

For queries or comments on templates, please contact:

Day 80 and Day 120 assessment report templates (containing guidance)

  • Note: instructions on how to delete green guidance text is in the cover page of the assessment report template

Day 150 joint assessment report templates and Day 180 CHMP list of outstanding issues

Day 180 joint assessment report templates

Generic medicinal products assessment report templates (containing guidance)

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