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EU establishes 4 different drug approval processes: 1) Centralized Procedure 2) Decentralized Procedure 3) National Procedure 4) Mutual Recognition Procedure. The Basic Regulation. Investigational New Drug Application.
Following a positive recommendation from the Agency, the European Commission takes around two months to approve a medicine.
The first clock-stop usually lasts 3 to 6 months and the second one 1 to 2 months. Overall, the assessment of a new medicine usually lasts around a year. Did you know..? The assessment time may be reduced to 150 days instead of 210 days, if the medicine developer is granted accelerated assessment.
Following a positive recommendation from the Agency, the European Commission takes around two months to approve a medicine.
The process of the centralized procedure is triggered when the applicant sends the letter announcing the intent to submit a MAA (letter of intent), which is usually done at least seven months prior to the targeted submission date.

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Obtaining an EU marketing authorisation, step-by-step Steps prior to submitting an application. Submission of the application. Assessment of the application. European Commission decision on the marketing authorisation. Voluntary sharing of market launch intentions: pilot project.
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. If EMA needs additional information to complete its validation of the application, it will ask the applicant to supply this by a deadline.
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