Assessment templates and guidance

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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 documents provide general guidance on the evaluation of the quality, non-clinical and clinical aspects of new drug applications and extension applications.

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: chmp_ar_templates@ema.europa.eu

Table of contents


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

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Document(s) Language Status First published Last updated Effective Date
Day 80 assessment report - Quality template with guidance rev. 07.18 (English only)   2009-09-01 2018-07-26 2018-08-16
Annex 1 - Active substance master file (ASMF) assessment report template - Applicant's part rev. 07.18 (English only)   2017-07-03 2018-07-26 2018-08-16
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 with guidance rev. 07.18 (English only)   2015-05-21 2018-07-26 2018-08-16
Day 80 assessment report - Clinical template with guidance rev.07.18 (English only)   2015-05-21 2018-07-26 2018-08-16
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 and D120 LOQ template with guidance rev. 07.18 (English only)   2015-05-21 2018-07-26 2018-08-16
Peer reviewers comments at day 100 (English only)   2017-07-03   2017-07-17

Related links

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

Day 100 member states' and peer review comments

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Document(s) Language Status First published Last updated Effective Date
CHMP-CAT-PRAC member comments on rapporteur’s reports (English only)   2017-07-03   2017-07-17

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

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Document(s) Language Status First published Last updated Effective Date
Day 150 joint assessment report - Quality template rev. 07.18 (English only)   2006-09-01 2018-07-26 2018-08-16
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 and list of outstanding issues template rev. 07.18 (English only)   2009-09-01 2018-07-26 2018-08-16

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. 07.18 (English only)   2006-09-01 2018-07-26 2018-08-16
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. 07.18 (English only)   2009-09-01 2018-07-26 2018-08-16

Day 120/180 CHMP assessment report templates

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Related links

  • See Day 80 assessment report overview and Day 120 list of questions template with guidance
  • See Day 150 joint assessment report overview and Day 180 list of outstanding issues template with guidance

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 (containing guidance)

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Similarity assessment

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Document(s) Language Status First published Last updated Effective Date
CHMP and rapporteurs' joint assessment report on derogation applicable to similar orphan products (English only)   2014-05-28 2018-07-26  
CHMP and rapporteurs' joint assessment report template and assessment on similarity rev. 07.18 (English only)   2014-05-28 2018-07-26 2018-08-16

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 for initial marketing authorisation application

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Document(s) Language Status First published Last updated Effective Date
PRAC D94 Rapporteur RMP assessment report template rev. 07.18 (English only)   2015-05-21 2018-07-26 2018-08-16

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