Submission dates

The timing and planning of the submission of applications and the timetable for assessment of applications is important for applicants and marketing-authorisation holders (MAHs). It is also important for the European Medicines Agency (EMA), and for the members and experts working on its Committees for Medicinal Products for Human Use (CHMP), Pharmacovigilance Risk Assessment (PRAC) and Advanced Therapies (CAT). Timing applications appropriately enables the working plan to be as efficient as possible.

Best practices on submission predictability

A report is available including recommendations to improve the precision, preparedness and communication of marketing authorisation application submissions:

Focus group on submission predictability: Final report

The report is based on a 2023 EMA exercise in monitoring submissions delays. This involved encouraging applicants to be proactive in their communication to EMA. Applicants had been informed of this exercise in advance.

EMA's focus group on submission predictability published the report in July 2024.

Representatives of pharmaceutical industry, EMA committees and national competent authorities take part in this group.

EMA advises applicants to consider the date of submission very carefully, particularly for full applications. They should also observe the joint guidance from EMA and Heads of Medicines Agencies below:

Best practice guide on measures improving predictability of submissions/responses and adherence to communicated submission/responses deadlines

Reference Number: EMA/488783/2017

Applicants should notify the Agency 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.

Deadlines and timetables

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:

• Procedural timetables