Accelerated assessment: shortened centralised assessment for major public health interest
Accelerated assessment shortens the CHMP's review of a centralised application from 210 to 150 days for a medicine of major public health interest.
Article 14(9) of Regulation (EC) No 726/2004 allows the CHMP, at the applicant's request, to assess an application in 150 days rather than 210 where the product is of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation. EMA's guideline on the procedure for accelerated assessment sets out how to request it and how the committee decides. Products admitted to the PRIME scheme are expected to qualify, but any applicant can ask.
The request is made before the application itself, with a justification that addresses the unmet medical need, the extent to which the product meets it and the strength of the evidence. The CHMP decides on eligibility at a plenary meeting, so the request must reach EMA in time for the meeting that precedes the intended submission; EMA asks for it at least two to three months ahead. The decision is on the timetable only; the standard of evidence does not change, and the committee can revert to the 210-day timetable during the procedure if major objections remain unresolved.
A 150-day review leaves little room for problems. The list of questions comes earlier, the clock-stop for responses is kept short, usually about one month, and any list of outstanding issues stage is compressed into the final weeks. Applicants therefore need the responses to most foreseeable questions ready at submission, and the product information, risk management plan and manufacturing data mature from the start.
What goes wrong: a justification that argues commercial importance or novelty rather than public health interest, which is refused; a dossier with known gaps, so the procedure reverts to the standard timetable and the time saved is lost together with credibility; and manufacturing or inspection issues that cannot be resolved in the shortened clock-stop. Accelerated assessment also does not shorten the Commission decision stage that follows the opinion, and it does not change the fee.
Under the new pharma package (not yet in force), the standard centralised assessment time is shortened for all applications, and medicines addressing an unmet medical need qualify for extended regulatory protection as well as faster assessment; see exclusivity changes.
Timing
The request is submitted at least two to three months before the planned application, and the CHMP decides on eligibility at the next plenary meeting. Once the procedure starts, the committee adopts its list of questions partway through the review, the clock-stop for responses is limited, usually to about one month, and the opinion follows by Day 150. If the committee reverts to the standard timetable the procedure continues to Day 210. The Commission decision then usually takes about two months.
Used in
Before requesting it, check the eligibility criteria and timetable for accelerated assessment in Workbench, with every answer cited to EMA guidance.
Related terms
- Centralised procedure: single EU marketing authorisation via EMAThe centralised procedure grants one marketing authorisation valid across the EU and EEA after a single EMA assessment and a Commission decision.
- CHMP: Committee for Medicinal Products for Human UseThe CHMP is the EMA committee that assesses centralised applications and referrals for human medicines and adopts the opinions behind Commission decisions.
- Conditional MA: conditional marketing authorisationA conditional marketing authorisation is a one-year, renewable EU authorisation granted on less complete data for medicines that meet an unmet need.
- Clock-stop: pause in the procedure timetableA clock-stop is a pause in a regulatory procedure's timetable while the applicant prepares responses to questions from the assessing authority.
- Scientific advice: EMA or national guidance on development before submissionScientific advice is formal guidance from EMA or a national authority on the studies and data a developer should generate before applying for an MA.
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