Assessment templates and guidance

The European Medicine Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) and Committee on Advanced Therapies (CAT) should use the assessment report templates and documents listed on this page for the assessment of any new application in the centralised procedure.

The template documents provide general guidance on the evaluation of the quality, non-clinical and clinical aspects of marketing authorisation applications and extension of marketing authorisation applications.

Since January 2025, EMA and the assessors manage the documents for both types of applications in SharePoint.

For applications started before January 2025, the rapporteurs circulate the assessment reports and comments via Eudralink.

Overview for marketing authorisation applications (for consultation only)

CHMP-CAT - D80-210 Overview to final EPAR - Rev 07.25 Revamp

This is a consultation version for reference to guidelines and structure integrated in the text and should not be used for the actual assessment. This is because the necessary version is created directly in the system for assessment team use (please refer to the relevant product folder in SharePoint).

Assessment report templates until Day 120

Day 80 assessment report - Quality template with guidance (Biologics) Rev. 03.25 - Revamp

Reference Number: rev 03.25 - Revamp

Day 80 assessment report - Quality template with guidance (Chemicals) Rev. 03.25 - Revamp

Reference Number: rev 03.25 - Revamp

Annex 1 - Active substance master file (ASMF) assessment report template - Applicant's part rev. 07.18

Legal effective date: 16/08/2018

Annex 1 - Active substance master file (ASMF) assessment report template - Restricted part rev. 06.17

Legal effective date: 17/07/2017

Day 80 assessment report - Non-clinical template with guidance - Rev 06.25 Revamp

Day 80 assessment report - Clinical template with guidance - Rev. 07.25 - Revamp

Day 80 assessment report - New active substance status template - Rev. 03. 23

Assessment report templates after Day 120

The word response template document, in which the applicant should respond to D120 LoQ/D180 LoOI, should be used for assessment of the responses to D120 LoQ/D180 LoOI. 

The template can be found on this webpage: Marketing authorisation templates

Day 150 or Day 195 joint response assessment report with guidance - Overview and list of outstanding issues template - Rev. 10.23

In use only for marketing authorisation applications started before January 2025 and for extension applications started before March 2025. Otherwise please use the revamped templates as per the process guideline.

Member states' comments

CHMP-CAT-PRAC member comments on rapporteur’s reports

Legal effective date: 17/07/2017

Re-examination assessment report template

(Co) Rapporteur (joint) assessment report of the grounds for the re-examination procedure - Rev. 05.21

Informed consent assessment report template

Informed consent application in accordance with Article 10c of Directive 2001/83/EC - Rev. 05. 21

Generic and hybrid medicinal products assessment report templates

Generics - Hybrids - Day 80 assessment report - Quality template with guidance - Rev. 05. 21

Generics - Hybrids - Day 80 assessment report - Non-clinical and clinical template with guidance - Rev. 05. 21

Generics - Hybrids - Day 80 assessment report overview and Day 120 list of outstanding issues template with guidance - Rev. 05. 21

This template below may apply for generic and hybrid applications only. For applications under any other legal basis, the template integrated in the revamp overview for the assessment of the RMP should be used.

Generics - Hybrids - PRAC D94 Rapporteur RMP assessment report template rev. 01.23

Reference Number: Rev. 01.23 Legal effective date: 16/08/2018

Generics - Hybrids - Day 150 or Day 195 joint report assessment report - Overview and D180 list of outstanding issues template with guidance - Rev. 05. 21

Similarity assessment report templates

CHMP and Rapporteurs' assessment report template on Similarity Rev. 01.25

Legal effective date: 15/07/2020

CHMP and rapporteurs' joint assessment report on derogation applicable to similar orphan products - Rev. 03.23

Other templates

Certification evaluation report

Peer review of the certification procedure

• Assessment templates and guidance for an ancillary medicinal substance incorporated in a medical device

Quick Response (QR) code

Quick Response (QR) code

Companion diagnostics ('in-vitro diagnostics')

Consultation on companion diagnostic - Assessment report template

For more information:

• Companion diagnostics ('in-vitro diagnostics')

Paediatric guidance

Structured guidance on the use of extrapolation

Reference Number: EMA/CHMP/13622/2022