Snapshot

The EMA Accelerated Assessment pathway has been developed by the European Medicines Agency of EU-EMA.

It is an abridged review (a reliance pathway).

Regional regulatory initiatives can help optimize the efficient use of an agency’s resources. The following countries participate in this initiative/pathway: EU-EMA

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. This time frame will be split into 3 phases of 90+30+30 days of assessment. The applicants will be allowed to have one month clock-stop 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. In case of advanced therapy medicinal products, due to the need to include more scientific committees in the review of the application, the 150-day timetable will be adapted differently and split into 2 phases of 120+30 days of assessment.