Assessment templates and guidance

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

For assessment reports templates for procedures that started before 28th May 2015 please contact: chmp_ar_templates@ema.europa.eu

For queries or comments on templates, please contact: chmp_ar_templates@ema.europa.eu

Table of contents


Day 80 assessment report templates and guidance documents

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Document(s) Language Status First published Last updated Effective Date
Day 80 assessment report - Quality guidance rev.10.16 (English only)   2009-09-01 2016-11-08 2016-11-20
D80 assessment report - Non-clinical guidance rev.10.16 (English only)   2016-05-25 2016-11-18 2016-11-20
D80 assessment report - Clinical guidance rev.10.16 (English only)   2016-05-25 2016-11-08 2016-11-20
D80 assessment report - Overview guidance rev.10.16 (English only)   2016-05-25 2016-11-08 2016-11-20
CHMP-CAT-PRAC member comments on rapporteur’s reports (English only)   2017-07-03   2017-07-17
Peer reviewers comments at day 100 (English only)   2017-07-03   2017-07-17

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Document(s) Language Status First published Last updated Effective Date
Day 80 assessment report - Quality template rev. 10.16 (English only)   2009-09-01 2016-11-08 2016-11-20
Annex 1 - Active substance master file (ASMF) assessment report template - Applicant's part rev. 06.17 (English only)   2017-07-03   2017-07-17
Annex 1 - Active substance master file (ASMF) assessment report template - Restricted part rev. 06.17 (English only)   2017-07-03   2017-07-17
Day 80 assessment report - Non-clinical template rev. 10.16 (English only)   2015-05-21 2016-11-18 2016-11-20
Day 80 assessment report - Clinical template rev.10.16 (English only)   2015-05-21 2016-11-08 2016-11-20
Day 80 assessment report - New active substance status template rev. 10.16 (English only)   2011-10-13 2016-11-08 2016-11-20
Day 80 assessment report - Overview template rev. 10.16 (English only)   2015-05-21 2016-11-08 2016-11-20

Day 150 joint assessment report templates

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Document(s) Language Status First published Last updated Effective Date
Day 150 joint response assessment report - Quality template rev. 10.16 (English only)   2006-09-01 2016-11-08 2016-11-20
Day 150 joint response assessment report - Non-clinical template rev. 10.16 (English only)   2006-09-01 2016-11-08 2016-11-20
Day 150 joint response assessment report - Clinical template rev. 10.16 (English only)   2006-09-01 2016-11-08 2016-11-20
Day 150 joint response assessment report - Overview template rev. 10.16 (English only)   2009-09-01 2016-11-08 2016-11-20

Day 180 joint assessment report templates

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Document(s) Language Status First published Last updated Effective Date
Day 180 joint response assessment report - Quality template rev. 10.16 (English only)   2006-09-01 2016-11-08 2016-11-20
Day 180 joint response assessment report - Non-clinical template rev. 10.16 (English only)   2006-09-01 2016-11-08 2016-11-20
Day 180 joint response assessment report - Clinical template rev. 10.16 (English only)   2006-09-01 2016-11-08 2016-11-20
Day 180 joint response assessment report - Overview template rev. 10.16 (English only)   2009-09-01 2016-11-08 2016-11-20

CHMP assessment report templates

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Document(s) Language Status First published Last updated Effective Date
Day 120 list of questions template rev. 10.16 (English only)   2015-05-21 2016-11-08 2016-11-20
Day 180 list of outstanding issues template rev. 10.16 (English only)   2009-09-01 2016-11-08 2016-11-20

Re-examination assessment report templates

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Document(s) Language Status First published Last updated Effective Date
(Co) Rapporteur (joint) assessment report of the grounds for the re-examination procedure rev. 06.17 (English only)   2017-07-03   2017-07-17

Informed consent assessment report template

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Document(s) Language Status First published Last updated Effective Date
Informed consent application in accordance with Article 10c of Directive 2001/83/EC, as amended rev.10.16 (English only)   2010-05-05 2016-11-08 2016-11-20

Generic medicinal products assessment report templates and guidance documents

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Document(s) Language Status First published Last updated Effective Date
Day 80 assessment report generics quality guidance rev.10.16 (English only)   2008-11-25 2016-11-08 2016-11-20
Day 80 assessment report non-clinical and clinical guidance - generics rev.10.16 (English only)   2015-07-08 2016-11-08 2016-11-20
Day 80 assessment report overview guidance - generics rev.10.16 (English only)   2015-07-08 2016-11-08 2016-11-20

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Document(s) Language Status First published Last updated Effective Date
Day 80 assessment report generics quality template rev. 10.16 (English only)   2008-11-24 2016-11-03 2016-11-20
Day 80 assessment report non-clinical and clinical - generic template rev. 10.16 (English only)   2015-07-08 2016-11-03 2016-11-20
Day 80 assessment report overview - generics template rev. 10.16 (English only)   2015-07-08 2016-11-03 2016-11-20
Day 120 list of questions - generics template rev. 10.16 (English only)   2015-07-08 2016-10-03 2016-11-20
Day 150 joint report assessment report overview generics template rev. 10.16 (English only)   2008-11-25 2016-11-08 2016-11-20
Day 180 list of outstanding issues generics template rev. 10.16 (English only)   2012-05-10 2016-11-08 2016-11-20
Day 180 joint assessment report generics template rev. 10.16 (English only)   2012-05-10 2016-11-08 2016-11-20

Similarity assessment

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Document(s) Language Status First published Last updated Effective Date
Joint CHMP and rapporteurs' joint assessment report on derogation applicable to similar orphan products (English only)   2014-05-28    
CHMP and rapporteurs' joint assessment report template on assessment of similarity (English only)   2014-05-28 2017-07-03 2017-07-17

Other templates

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Document(s) Language Status First published Last updated Effective Date
Certification evaluation report (English only)   2014-12-17    
Peer review of the certification procedure (English only)   2014-12-17    
CHMP/CAT member comments on rapporteurs’ reports (English only)   2010-05-19 2013-03-05 2013-02-21
Scientific recommendation on classification of advance therapy medicinal products (ATMP) (English only)   2014-12-17    

PRAC RMP assessment report template

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Document(s) Language Status First published Last updated Effective Date
PRAC D94 Rapporteur RMP risk assessment report rev. 10.16 (English only)   2015-05-21 2016-11-08 2016-11-20

Quick Response (QR) code

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Document(s) Language Status First published Last updated Effective Date
Quick Response (QR) code (English only)   2016-01-18