ArticleFrontiers in medicine2025
Impact of regulatory measures on the approval timelines of advanced therapy medicinal products by the European Medicines Agency.
Article in Frontiers in medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Trends in oncology marketing applications in the European Union: a five-year systematic review.Frontiers in pharmacology · 2025Pooled it
- Advanced therapy medicinal products in Saudi Arabia: Regulation and development.Regenerative therapy · 2026Review
- Why promising ATMPs fail to reach patients: a qualitative stakeholder-informed analysis of cell therapy access in Europe.Journal of translational medicine · 2026Article
- CRISPR-Cas9 Therapeutics in Early Clinical Development: Delivery and Molecular Diagnostics.Cells · 2026Review
- Artificial Intelligence and the Transformation of Cell and Gene Therapy Development.Pharmaceutics · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Introduction: The study examines the impact of regulatory tools, including PRIority MEdicines (PRIME) scheme, on the marketing authorization (MA) timeline of advanced therapy medicinal products (ATMPs) approved by the European Medicines Agency (EMA). Methods: A retrospective analysis of EMA-approved ATMPs was conducted using publicly available European public assessment reports. Timelines from submission to approval, regulatory pathways, frequency of scientific advice (SA), and use of supportive mechanisms such as PRIME and Orphan designation were analyzed. Results: A total of 27 ATMPs were approved in the EU, 52% of which received PRIME designation and 74% held orphan status. PRIME participation was associated with a 42.7% reduction in time to MA ( Discussion: The PRIME scheme facilitates earlier MA by supporting developers in addressing regulatory requirements more efficiently, shortening time to approval by approximately one year. The study underscores the value of early and frequent engagement with regulatory authorities and the need for tailored regulatory frameworks to support smoother approval processes. These insights can help developers better plan and optimize regulatory strategies. By demonstrating the measurable benefits of PRIME, this research supports its continued use to accelerate access for patients with high unmet medical needs.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.