Work

Impact of regulatory measures on the approval timelines of advanced therapy medicinal products by the European Medicines Agency

Year: 2025

Type: article

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: = 0.021). PRIME-designated products also had fewer and shorter clock stops and more frequent scientific advice interactions. 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.

Source: Frontiers in Medicine

DOI: 10.3389/fmed.2025.1623689

Authors: Simonita Alaburde, Justinas Ivaska, Greta Kaspute, Tatjana Ivaskiene

Institutions: State Research Institute Centre for Innovative Medicine, Vilnius University

Language: English

Topic: Biomedical Ethics and Regulation

Subfield: Issues, ethics and legal aspects

Field: Nursing

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,801