2. Accelerated assessment
Accelerated assessment reduces the timeframe for the EMA CHMP to review a marketing-authorisation application (MAA). Evaluating a MAA 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. A request for accelerated assessment requires a complete dossier to be available at the time of submission.
Accelerated assessment procedures are set up to:
- Meet the expectations of patients, and
- take into account the increasingly rapid progress of science and therapies.
Accelerated assessment may be requested when an application is submitted for a product:
- that is of major interest from the point of view of public health and
- in particular from the viewpoint of therapeutic innovation.
The request needs to be well justified. If the CHMP accepts the request, the timeframe for the evaluation will be reduced to 150 days. This time frame will be split into 3 phases of 90+30+30 days of assessment. A one-month clock-stop will be allowed by default for preparation of responses to Day 90 List of Questions and no clock stop by default after Day 120 List of Outstanding Issues. The CHMP will decide on the second clock stop based on:
- the request;
- the justifications presented;
- the recommendations of the rapporteurs.
This decision has no impact on the eventual CHMP opinion on whether a marketing authorisation should be granted.
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. For advanced therapies, a specific timetable applies.
Article 14 (9) of Regulation (EC) No 726/2004
Recital 33 of Regulation (EC) No 726/2004
Guideline on the scientific application and the practical arrangements necessary to implement the procedure for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004 (25 February 2016 EMA/CHMP/671361/2015 Rev. 1)
Of note: 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. PRIME is a scheme launched by the EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier.
The scheme focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options. These medicines are considered priority medicines by EMA. To be accepted for PRIME, a medicine has to show its potential to benefit patients with unmet medical needs based on early clinical data.