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.
Table of contents
- Day 80 and Day 120 assessment report templates (containing guidance)
- Day 100 member states’ and peer review comments
- Day 150 joint assessment report templates and Day 180 CHMP list of outstanding issues
- Day 180 joint assessment report templates
- Re-examination assessment report templates
- Informed consent assessment report template
- Generic medicinal products assessment report templates (containing guidance)
- Similarity assessment
- Other templates
- PRAC RMP assessment report template for initial marketing authorisation application
- Quick Response (QR) code