Revamp of marketing authorisation assessment templates
The European Medicines Agency (EMA) has been revising its assessment report templates and reviewing how they are completed to reduce duplication and improve efficiency.
HumanCorporate
Assessing a marketing authorisation application involves producing multiple, interrelated assessment reports.
EMA has been revising its templates and re-evaluating how they are completed. This reduces duplication and improves efficiency.
This initiative has the following key objectives:
- Eliminating unnecessary duplication
- Enhancing consistency across reports
- Streamlining processes to save time and resources
EMA's Committee for Medicinal Products for Human Use (CHMP) and EMA staff lead this initiative, in close collaboration with the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Advanced Therapies (CAT). Representatives from the pharmaceutical industry also provide comments on templates and feedback on approaches.
To access the assessment templates, use the link below. Templates revised as part of this initiative are labelled 'Revamp' in the title:
Pilot outcome: applicants pre-filling parts of D80 reports
EMA ran a pilot aimed at improving the completion of the day 80 (D80) quality, non clinical and clinical assessment reports. During this pilot, EMA asked applicants to pre-fill the assessment reports with factual information.
This was part of EMA's initiative to streamline the assessment templates.
The pilot followed a revision of the D80 assessment templates. This revision introduced a clear distinction between factual data provided by the applicant and the assessor’s evaluation of that data.
While the approach was well intentioned and aligned with efficiency objectives, the pilot showed that it did not deliver overall benefits for either assessors or applicants.
Based on the overall outcomes of the pilot, EMA has put forward three recommendations for future consideration. EMA will inform applicants if any of these recommendations are incorporated into general guidance.
The pilot recommendations are as follows:
- Conduct a minimum of 5 more pilots for applicants pre-filling the quality reports only (as just 3 were included in the pilot)
- Only request pre-completion of tables and not the text for the non-clinical and clinical reports
- Allow assessors to ask questions during the assessment period, without waiting until formal adoption by the Committee
More information is available in the pilot report below.
Page update history
An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.
8 May 2026
Page first published.