2. Pre-submission

1. Pre-submission

The applicant should carefully consider all regulatory and logistical issues prior to submission of a marketing authorisation application (MAA), notably, which procedural approach to take. In the following, we will concentrate on the application for a centralised procedure, bearing in mind, that the principles apply to strictly national, mutual recognition procedure (MRP) and decentralised procedure (DCP) as well and addressing differences where appropriate.

To find out whether a product can be evaluated under the centralised procedure, an eligibility request should always be submitted using the Pre-submission request form (Eligibility) accompanied by a justification between 18 and, at the latest, 7 months before the MAA is filed with the EMA. At this point it could be submitted as part of the letter of intent to submit (pre-submission request form (intent to submit MAA)). Re-confirmation of the submission date initially communicated to EMA in this very letter, or information to EMA of any delays or cancellations should be carried out.

Appointment of Rapporteurs
The Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC) appoint (co-)rapporteurs to conduct the scientific assessment. Additionally for advanced therapy medicinal products, the Committee for Advanced Therapies (CAT) is also involved in appointing (co-)rapporteurs.

2. Pre-submission contact with regulatory agencies

Various activities, directly involving regulators, in preparation of a marketing authorisation application (MAA) can and should take place. A brief overview is given in the following graph (adapted from an EMA presentation) with an approximate timeline in which such activities may occur.

Figure 1: The approximate timelines of activities before a submission are denoted as ‘minus months’ using the notation

*Of note: Scientific advice in various forms is available throughout the development of a medicine (usually not for free) and not only in a relatively short time frame before submission of a MAA.

Of particular importance is the Pre-submission meeting with EMA staff on request by the company, in order to obtain further information and guidance. It is strongly recommended by EMA, even for experienced users of the centralised procedure.

Such a meeting will normally take place 6 to 7 months before the submission date.

The pre-submission meeting are organised to:

• Discuss legal, regulatory and scientific issues
• Discuss final practical & regulatory aspects of upcoming application
• Clarify application-specific issues not addressed on the EMA website
• Ensure that application will meet all requirements for validation
• Reconfirm various administrative/procedural/legal issues; requirements may have changed

In case of applications under the mutual recognition procedure (MRP), decentralised (DCP) or national procedure (NP), pre-submission contacts are also possible with the relevant NCA(s) and are equally useful.

Answers to many questions in relation to applications via the centralised procedure may be found on the EMA website, shown below.

Having obtained all the information needed, the company can finalise the application dossier.