CRED ERP 25

07/07/2025

SUBMISSION OF THE APPLICATION

● SUBMISSION OF THE APPLICATION Applicants should use the electronic common technical document (eCTD) format and submit the application through the eSubmission gateway or web client [1].

VALIDATION OF THE APPLICATION

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EMA performs a technical validation of the applications it receives. The objective is to make sure all

essential regulatory elements required for scientific assessment are included in the application prior to the

start of the procedure [1].

The Organisation for Professionals in Regulatory Affairs

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ASSESSMENT OF THE APPLICATION

● SCIENTIFIC EVALUATION The Committee for Medicinal Products for Human Use (CHMP) evaluates marketing authorisation applications submitted through the centralised procedure, with input from the Pharmacovigilance Risk Assessment Committee (PRAC) on aspects of the risk-management plan and the Committee for Advanced Therapies (CAT) for advanced-therapy medicines.

This takes up to 210 active days.

The committees are composed of members from each of the EU Member States and from Iceland and Norway, plus co-opted members who provide additional expertise in particular scientific areas.

CHMP SCIENTIFIC OPINION

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After the evaluation, the CHMP issues a scientific opinion on whether the medicine may be authorised or not. EMA sends this opinion to the European Commission, which issues the marketing authorisation .

EMA then publishes a summary of the committee's opinion.

The Organisation for Professionals in Regulatory Affairs

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