Assessment templates and 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. 

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

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

For more information:

• Companion diagnostics ('in-vitro diagnostics')