A Systematic Review of the Regulatory Drug Approval Pathways in the European Medicine Agency and Other Regulated Markets

Regulatory agencies have developed expedited drug approval pathways to accelerate patient access to therapies addressing unmet medical needs, particularly in oncology and rare diseases. The European Medicines Agency (EMA) has introduced several such pathways; however, their efficiency compared to other global regulators remains a subject of evaluation. This systematic review aimed to evaluate regulatory drug approval pathways within the EMA and compare them with other regulated markets, focusing on innovation, review timelines, regulatory productivity, and clinical outcomes in high-need therapeutic areas. A comprehensive literature search was conducted across PubMed, Web of Science, and ScienceDirect databases covering studies published between 2015 and 2025. A total of 320 records were identified, of which 28 studies met the inclusion criteria after screening. Data extraction and methodological quality assessment were performed using the AMSTAR 2 checklist. The EMA provides multiple expedited pathways, including PRIME, Accelerated Assessment (A. As), Conditional Marketing Authorisation (CMA), and Exceptional Circumstances Approval. Despite these initiatives, their utilization remains lower compared to programs offered by the U.S. Food and Drug Administration (FDA). Median review timelines under EMA expedited pathways range from 315 to 476 days, which are longer than FDA timelines (175-192 days). Oncology drugs within EMA pathways experience accelerated progression, reducing development timelines by approximately 2.5 years. However, limited uptake of PRIME, extensive post-marketing obligations, annual renewal requirements (particularly for CMA), and administrative complexities contribute to delayed approvals relative to the U.S. EMA expedited pathways play a critical role in facilitating early access to innovative therapies while ensuring robust evidence generation and regulatory oversight. However, their overall effectiveness is constrained by longer review timelines and regulatory complexities. Greater harmonization of global regulatory frameworks and optimization of evidence requirements may enhance the efficiency and impact of accelerated approval pathways worldwide.