Assessment templates and guidance
Table of contents
- Day 80 and Day 120 assessment report templates (containing guidance)
- Day 100 member states' and peer review comments
- Day 150 or Day 195 joint assessment report templates and Day 180 CHMP list of outstanding issues
- Re-examination assessment report templates
- Informed consent assessment report template
- Generic and hybrid medicinal products assessment report templates (containing guidance)
- Similarity assessment
- Other templates
- PRAC RMP assessment report template for initial marketing authorisation application and extension applications
- Quick Response (QR) code
- Companion diagnostics ('in-vitro diagnostics')
- Paediatric guidance
The Committee for Medicinal Products for Human Use (CHMP) and Committee on Advanced Therapies (CAT) should use the assessment report templates and documents listed below for the assessment of any new application in the centralised procedure.
The documents provide general guidance on the evaluation of the quality, non-clinical and clinical aspects of new drug applications and extension applications.
CHMP, CAT and (Co)Rapporteurs should circulate the assessment reports and comments via Eudralink.
Assessors should always submit assessment reports and comments for initial marketing authorisation applications to:
- the EMA product lead and product assistant (whose names are listed on the dashboard for national competent authorities);
- the product shared mailbox (whose format is always 'product name-product number' in one word, followed by '@ema.europa.eu');
- the product's dedicated initial MAA mailbox (whose format is always 'MAAproduct number' in one word, followed by '@ema.europa.eu').
The product number is always composed of 4 digits including xxxx if needed.
Assessors should have the Agency's styles installed in Microsoft Word to ensure optimal use of the templates.
For technical support with using the templates, please use EMA service desk.
To raise other queries or comments about the templates, please contact chmp_ar_templates@ema.europa.eu.
-
List item
Day 80 assessment report - Quality template with guidance - Rev. 05. 21 (DOCX/143.11 KB)
First published: 01/09/2009
Last updated: 25/06/2021
05. 21 -
List item
Annex 1 - Active substance master file (ASMF) assessment report template - Applicant's part rev. 07.18 (DOCX/34.73 KB)
First published: 03/07/2017
Last updated: 26/07/2018
Legal effective date: 16/08/2018 -
List item
Annex 1 - Active substance master file (ASMF) assessment report template - Restricted part rev. 06.17 (DOCX/41.67 KB)
First published: 03/07/2017
Last updated: 03/07/2017
Legal effective date: 17/07/2017 -
List item
Day 80 assessment report - Non-clinical template with guidance - Rev.10.23 Revamp (DOCX/154.04 KB)
First published: 21/05/2015
Last updated: 12/10/2023 -
List item
Day 80 assessment report - Clinical template with guidance - Rev.10.23 Revamp (DOCX/722.25 KB)
First published: 21/05/2015
Last updated: 12/10/2023 -
List item
Day 80 assessment report - New active substance status template - Rev. 03. 23 (DOCX/44.04 KB)
First published: 13/10/2011
Last updated: 14/03/2023 -
List item
Day 80 assessment report - Overview and D120 LOQ template with guidance - Rev. 10.23 (DOCX/233.58 KB)
First published: 21/05/2015
Last updated: 20/10/2023 -
List item
Peer reviewers comments at day 100 (DOCX/33.84 KB)
First published: 03/07/2017
Last updated: 03/07/2017
Legal effective date: 17/07/2017
- Note: instructions on how to delete green guidance text is in the cover page of the assessment report template.
-
List item
Day 150 or Day 195 joint assessment report - Quality template - Rev. 05. 21 (DOCX/34.15 KB)
First published: 01/09/2006
Last updated: 25/06/2021 -
List item
Day 150 or Day 195 joint response assessment report - Non-clinical template - Rev. 05. 21 (DOCX/32.02 KB)
First published: 01/09/2006
Last updated: 25/06/2021 -
List item
Day 150 or Day 195 joint response assessment report - Clinical template - Rev. 05. 21 (DOCX/35.22 KB)
First published: 01/09/2006
Last updated: 25/06/2021 -
List item
Day 150 or Day 195 joint response assessment report - Overview and list of outstanding issues template - Rev. 10.23 (DOCX/119.59 KB)
First published: 01/09/2009
Last updated: 20/10/2023
-
List item
Generics - Hybrids - Day 80 assessment report - Quality template with guidance - Rev. 05. 21 (DOCX/78.78 KB)
First published: 25/11/2008
Last updated: 25/06/2021 -
List item
Generics - Hybrids - Day 80 assessment report - Non-clinical and clinical template with guidance - Rev. 05. 21 (DOCX/76.55 KB)
First published: 08/07/2015
Last updated: 25/06/2021 -
List item
Generics - Hybrids - Day 80 assessment report overview and D 120 list of outstanding issues template with guidance - Rev. 05. 21 (DOCX/132.5 KB)
First published: 08/07/2015
Last updated: 25/06/2021 -
List item
Generics - Hybrids - Day 150 or Day 195 joint report assessment report - Overview and D180 list of outstanding issues template with guidance - Rev. 05. 21 (DOCX/96.94 KB)
First published: 25/11/2008
Last updated: 25/06/2021
-
List item
CHMP and rapporteurs' joint assessment report on derogation applicable to similar orphan products - Rev. 03.23 (DOCX/140.49 KB)
First published: 28/05/2014
Last updated: 14/03/2023 -
List item
CHMP and Rapporteurs' assessment report template on Similarity Rev. 03.23 (DOCX/53.28 KB)
First published: 28/05/2014
Last updated: 14/03/2023
Legal effective date: 15/07/2020
-
List item
Certification evaluation report (DOC/210 KB)
First published: 17/12/2014
Last updated: 17/12/2014 -
List item
Peer review of the certification procedure (DOC/126.5 KB)
First published: 17/12/2014
Last updated: 17/12/2014 -
List item
CHMP/CAT member comments on rapporteurs’ reports (DOCX/33.47 KB)
First published: 19/05/2010
Last updated: 05/03/2013
Legal effective date: 21/02/2013
For more information: