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:

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.