Accelerated Approval: A Comparative Analysis of EU and US Regulatory Pathways

by Odelle Technology

The journey from drug discovery to market approval is complex and time-consuming, often taking over a decade and billions of dollars. In response to the urgent need for treatments addressing severe or life-threatening conditions, both the European Union (EU) and the United States (US) have implemented expedited approval pathways. This blog explores the key similarities and differences between the EU and US regulatory initiatives for accelerated approval.

EU Regulatory Initiatives:

1. Conditional Marketing Authorization (CMA): Introduced in 2006, CMA allows conditional approval for drugs addressing unmet medical needs. Additional data post-approval is required to confirm clinical benefit.

2. Adaptive Pathway: A pilot project (2014–2016) focused on accelerating access to innovative medicines through iterative development and real-world evidence collection.

3. Priority Medicines Scheme (PRIME): Launched in 2016, PRIME provides early and enhanced regulatory support for promising therapies targeting unmet medical needs.

4. Accelerated Assessment: Similar to US Accelerated Approval, this pathway reduces the evaluation period for Marketing Authorization Applications (MAA) from 210 to 150 days.

US Expedited Programs:

1. Priority Review Designation (PR): Established in 1992, PR shortens the review time for drugs treating severe or life-threatening illnesses, prioritizing therapies with potential benefits beyond existing treatments.

2. Accelerated Approval (AA): Also launched in 1992, AA allows approval based on surrogate endpoints, applied to serious conditions with unmet needs.

3. Fast-Track Designation (FTD): Introduced in 1997, FTD expedites development and review of drugs addressing unmet needs, facilitating communication between the FDA and sponsors.

4. Breakthrough Therapy Designation (BTD): Launched in 2012, BTD accelerates development of promising therapies, granted based on preliminary clinical evidence.

Key Considerations:

– Both EU and US require preclinical testing followed by clinical trials for drug approval.

– EU emphasizes iterative development and real-world evidence collection.

– FDA evaluates surrogate or intermediate clinical endpoints based on scientific support.

– Adequate and well-controlled studies are essential for demonstrating a drug’s effect.


While both regions share the goal of accelerating access to effective treatments, their pathways and criteria differ. The EU’s adaptive approach and the US’s targeted programs collectively contribute to advancing medical innovation and benefiting patients worldwide.

This comparative analysis underscores the importance of regulatory initiatives in expediting access to life-saving medicines while ensuring safety and efficacy. Collaboration between regulators, developers, and stakeholders is essential for navigating the complexities of drug approval and bringing innovative therapies to patients in need.

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