Timing submission of applications appropriately enables the working plan to be as efficient as possible.
In addition to marketing-authorisation holders, this is important for EMA and for members and experts working on the following committees:
For more information, see:
EMA advises applicants to consider the submission date very carefully, particularly for full applications.
Early and open engagement with EMA and rapporteurs is encouraged prior to submission.
Applicants should observe the joint guidance from EMA and Heads of Medicines Agencies available below.
Applicants must also notify EMA and the CHMP, PRAC or CAT rapporteurs and co-rapporteurs of their actual submission date.
For full applications, see also the question on 'How should I notify a change in the intended submission date of my application?' in the Pre-authorisation guidance.
EMA's focus group on submission predictability made available a report including recommendations to improve the precision, preparedness and communication of marketing authorisation application submissions.
Representatives of pharmaceutical industry, EMA committees and national competent authorities take part in this focus group.
The report is based on a 2025 EMA exercise in monitoring submissions delays. It builds on a similar exercise conducted in 2023.
The exercise involved encouraging applicants to be proactive in their communication to EMA. Applicants were informed of the exercise in advance.
Timetables are published as a generic calendar and are for the information and use of applicants, MAHs, the European Medicines Agency, CHMP, PRAC or CAT members and assessment teams.
See the full list of procedural timetables below:
EMA is facilitating an information day to enhance common understanding, raise awareness of the challenges for EU regulatory network and to share best practices for planning and preparing submissions, as well as communicating changes.
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.
The tracking of updates begins in April 2026.
20 April 2026
New focus group on submission predictability report published. The report is based on a 2025 EMA exercise in monitoring submissions delays.