template table cover letter european medicines agency

Assessment templates and guidance

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  [email protected] . 

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

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

English (EN) (143.11 KB - DOCX)

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

English (EN) (34.73 KB - DOCX)

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

English (EN) (41.67 KB - DOCX)

Day 80 assessment report - Non-clinical template with guidance - Rev.10.23 Revamp

English (EN) (154.04 KB - DOCX)

Day 80 assessment report - Clinical template with guidance - Rev.04.24 Revamp

English (EN) (697.58 KB - DOCX)

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

English (EN) (44.04 KB - DOCX)

Day 80 assessment report - Overview and D120 LOQ template with guidance - Rev. 10.23

English (EN) (233.58 KB - DOCX)

Peer reviewers comments at day 100

English (EN) (33.84 KB - DOCX)

• 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

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

English (EN) (32.03 KB - DOCX)

Day 150 or Day 195 joint assessment report templates and Day 180 CHMP list of outstanding issues

Day 150 or Day 195 joint assessment report - Quality template - Rev. 05. 21

English (EN) (34.15 KB - DOCX)

Day 150 or Day 195 joint response assessment report - Non-clinical template - Rev. 05. 21

English (EN) (32.02 KB - DOCX)

Day 150 or Day 195 joint response assessment report - Clinical template - Rev. 05. 21

English (EN) (35.22 KB - DOCX)

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

English (EN) (119.59 KB - DOCX)

Re-examination assessment report templates

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

English (EN) (45.5 KB - DOCX)

Informed consent assessment report template

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

English (EN) (89.23 KB - DOCX)

Generic and hybrid medicinal products assessment report templates (containing guidance)

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

English (EN) (78.78 KB - DOCX)

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

English (EN) (76.55 KB - DOCX)

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

English (EN) (132.5 KB - DOCX)

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

English (EN) (96.94 KB - DOCX)

Similarity assessment

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

English (EN) (140.49 KB - DOCX)

CHMP and Rapporteurs' assessment report template on Similarity Rev. 03.23

English (EN) (53.28 KB - DOCX)

Other templates

Certification evaluation report

English (EN) (210 KB - DOC)

Peer review of the certification procedure

English (EN) (126.5 KB - DOC)

CHMP/CAT member comments on rapporteurs’ reports

English (EN) (33.47 KB - DOCX)

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

PRAC RMP assessment report template for initial marketing authorisation application and extension applications

PRAC D94 Rapporteur RMP assessment report template rev. 01.23

English (EN) (76.78 KB - DOCX)

Quick Response (QR) code

English (EN) (54 KB - DOC)

Companion diagnostics ('in-vitro diagnostics')

Consultation on companion diagnostic - Assessment report template

English (EN) (140.95 KB - DOCX)

For more information:

• Companion diagnostics ('in-vitro diagnostics')

Paediatric guidance

Structured guidance on the use of extrapolation

English (EN) (686.03 KB - PDF)

• Regulatory and procedural guidance

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