Accelerated assessment is a shortened evaluation of a marketing authorisation application within the European Union’s centralised procedure. The Committee for Medicinal Products for Human Use (CHMP) can reduce the active evaluation period from 210 to 150 days if the medicinal product is expected to be of major interest for public health, particularly in terms of therapeutic innovation. The statutory evaluation standards for quality, safety, and efficacy remain unchanged.
Requirements and Application
Accelerated assessment is not the standard route for every centralised application. The applicant must justify why the medicinal product meets the requirement of major public health interest. Therapeutic innovation is explicitly a decisive factor. The CHMP decides whether the shortened timeline will be applied based on the application, the submitted justification, and the recommendation of its rapporteurs.
Early coordination is essential because the shortened deadline cannot replace preparation. Prior to submitting the marketing authorisation application, applicants can discuss the expected data package, the risk management plan, and potential GCP and GMP inspections. If inspections are required, they should be integrated into the process in a timely manner. The decision on accelerated assessment does not prejudice the subsequent CHMP opinion on the product’s eligibility for authorisation.
Evaluation Period and Procedural Discipline
The deadline refers to the active time of the scientific evaluation. Interruptions to the evaluation clock, during which the applicant prepares and submits additional information, do not count towards this active time. Therefore, the actual calendar duration cannot be derived from the 150 days alone. The quality and completeness of the dossier remain particularly significant, as responses to questions, inspections, and committee consultations must be prepared within a tighter active rhythm.
The shortened evaluation is not a lowering of scientific standards. The CHMP continues to assess the benefits and risks as well as the quality of the medicinal product. The statutory requirements of the centralised authorisation procedure, the requirements for Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP), and the review of the risk management plan also apply without restriction. It is the evaluation period that is accelerated, not the standard of proof.
Distinction from Conditional Marketing Authorisation and PRIME
Accelerated assessment must be distinguished from conditional marketing authorisation. A conditional marketing authorisation concerns the manner in which an approval can be granted despite data still to be supplemented, and is linked to specific obligations. In contrast, accelerated assessment only decides on the duration of the evaluation procedure. It changes neither the type of the subsequent authorisation nor the requirements for the decision on benefits and risks.
Accelerated assessment also differs significantly from PRIME. PRIME supports drug developers early during development. Accelerated assessment only begins with the marketing authorisation application. A medicinal product with PRIME access may be considered for it upon submission, but must submit the corresponding application and justification. PRIME is therefore not an automatic fast-track to authorisation.
The possibility is therefore primarily a matter of early regulatory strategy. Applicants must not only explain the medical added value but also credibly demonstrate that the dossier is manageable within the tighter process. Any incompleteness identified later is not cured by the status. The CHMP can request necessary clarifications and bases its decision on the professional recommendation of the rapporteurs. The acceleration is intended to facilitate access to important innovations without relativising the quality of the evaluation.
Reliable resource planning is therefore necessary for all parties involved. It must secure technical evaluations, data provision, quality control, and regulatory coordination in parallel, so that the shortened active period can be used without sacrificing traceability and compliance.
The requirements are assessed on a case-by-case basis.
The decision is communicated to the applicant with a statement of reasons.
Relevance for clinical trials
An accelerated assessment plan increases the demand for the reliability and availability of clinical evidence. Study reports, analysis plans, safety evaluations, database locks, and documentation on trial sites must be prepared at the time of submission so that queries can be answered without avoidable delays. The study organisation must also ensure that new data, inspection findings, and changes to the risk management plan are evaluated promptly and consistently.
Full-service CROs like Mediconomics provide support through integrated project management, monitoring, data management, biostatistics, pharmacovigilance, and medical writing. They can check dossier readiness, coordinate interfaces between clinical data and regulatory modules, prepare response packages to questions, and support the timely provision of study documents and safety information within a demanding evaluation rhythm.
Frequently Asked Questions (FAQ)
Does accelerated assessment reduce the requirements for efficacy data?
No. The evaluation period is shortened, but the scientific standards for quality, safety, and efficacy remain in place.
Does the 150-day deadline always apply as a calendar deadline?
No. It refers to the active evaluation time; clock stops for additional information are excluded from this.
Is PRIME a requirement for accelerated assessment?
No. PRIME can support an early expectation, but it replaces neither the application nor the decision of the CHMP.
Regulatory References
- Regulation (EC) No 726/2004, Article 14(9) – enables accelerated assessment in the centralised procedure.
- Regulation (EC) No 726/2004, Recital 33 – highlights public health interest and innovation.
- EMA Guideline on Accelerated Assessment – describes the application and practical implementation.
- Regulation (EC) No 726/2004, Article 14a – regulates conditional marketing authorisation, which is to be distinguished from this.