2-3 months before submitting marketing authorization application

With marketing authorization application

With marketing authorization application

Proof of concept (with the exception of SME and academic proof of principle/first human research)

Disclosure following the CHMP meeting

Not specified

Not specified

40 days after the request is received and the process has begun

If the CHMP accepts the request, the evaluation period will be reduced from 210 days to 150 days

Basically, it is divided into three stages of 90+30+30 days, but in the case of advanced therapy medicinal products, it is divided into two stages of 120+30 days

Demonstrate positive benefitrisk balance, based on scientific data, pending confirmation

Authorization valid for one year, on a renewable basis

Once the comprehensive data are provided, it can become a “standard” marketing authorization

Comprehensive data cannot be provided

Reviewed annually to reassess the risk-benefit balance, in an annual reassessment procedure

Will normally not lead to the completion of a full dossier and therefore not become a “standard” marketing authorization

Early appointment of CHMP or CAT rapporteur

Kick-off meeting with rapporteur and multidisciplinary group of experts from EMA/European medicines regulatory network

Appointment of PRIME Scientific Coordinator

Iterative scientific advice on overall development plans and key issues

Expedited follow-up scientific advice (under certain criteria) with shortened timelines

Submission readiness meeting

Confirmation of potential accelerated assessment