Evaluating a marketing-authorisation application under the centralised procedure can take up to 210 days, not counting clock stops when applicants have to provide additional information. On request, the CHMP can reduce the timeframe to 150 days if the applicant provides sufficient justification for an accelerated assessment.
Any request for accelerated assessment should be made at least two to three months before submitting the marketing-authorisation application.
Before submitting a request for accelerated assessment, applicants should seek guidance from the EMA procedure manager to ensure timely submission of their request.
EMA strongly recommends that applicants request a pre-submission meeting six to seven months before submission to prepare for evaluation under accelerated assessment. In this meeting, they can discuss their proposal for accelerated assessment with the Agency and rapporteurs from the CHMP and any other committees concerned, such as the Pharmacovigilance Risk Assessment Committee (PRAC) or the Committee for Advanced Therapies (CAT). They can present the data package and risk management plan they intend to include in their application.
The request for a pre-submission meeting should be sent electronically to EMA together with supporting documentation.
Under the PRIME scheme launched in March 2016, it is now possible for applicants to receive confirmation during the clinical development phase that their medicine might potentially be eligible for accelerated assessment.
Applicants for accelerated assessment should justify their claim that the medicinal product is expected to be of major public health interest, particularly from the point of view of therapeutic innovation.
For details, please see pre-submission guidance question: Is my product eligible for an accelerated assessment?
The Agency has a legal obligation to verify that manufacturers applying for marketing authorisation as well as the studies they submit comply with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).
Applicants should provide information concerning GMP and GCP aspects so that routine GCP and pre-approval GMP inspections can be integrated into the accelerated assessment procedure.
If a need for an inspection is identified, it will be requested as early as possible in the evaluation procedure.
For details, please see pre-submission guidance questions:
Update: To submit an accelerated assessment request, applicants should complete the below information and send it via EMA service desk, selecting the tab 'Business Services', category 'Human Regulatory'. The subcategory to be selected is 'Pre-Submission Phase - Human', followed by the sub-option: 'Accelerated Assessment Request'.
If you do not have an EMA account, please create it via the EMA Account Management portal. For further information or guidance about how to create an EMA Account reference the guidance 'Create an EMA Account'.
After the rapporteurs have received the request, they will produce a briefing note including their recommendations regarding an accelerated assessment.
If necessary, the CHMP may request clarifications from the applicant. The CHMP will make a decision based on:
This decision has no impact on the eventual CHMP opinion on whether a marketing authorisation should be granted.
The CHMP conclusions will be communicated to the applicant and the reasons for accepting or rejecting the request will also be summarised in the CHMP assessment report.
If a request for an accelerated assessment procedure is granted, the CHMP will take into consideration the standard timetable agreed for the accelerated assessment procedure.
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Update: For advanced therapies, a specific timetable applies. |
The accelerated assessment procedure is provided for by recital 33 and Article 14(9) of Regulation (EC) No 726/2004.
See also: