Insights

The European Medicines Agency (EMA) has recently strengthened its scientific advice framework for medicines targeting major public health threats, including antimicrobial resistance (AMR) and emerging infectious diseases. Through the Emergency Task Force (ETF), EMA now offers a more integrated and coordinated approach, bringing together regulatory, clinical trial, and ethics expertise in a single scientific advice process.

A key component of this initiative is the Scientific Advice to facilitate Clinical Trial Authorisations (SA-CTA), designed to help sponsors align early on both clinical development strategies and regulatory expectations. The SA-CTA guidance clarifies how applicants can receive consolidated feedback that supports robust trial design while reducing the risk of delays during clinical trial authorisation and later marketing authorisation procedures.

According to the SA-CTA guidance, applicants can request this advice by:

• Submitting a focused list of questions addressing key aspects of clinical development and regulatory strategy
• Clearly explaining how the proposed clinical trial(s) support both trial authorisation and future benefit–risk assessment
• Applying via the EMA IRIS portal, following a defined timetable and documentation package
• Benefiting from coordinated input involving the ETF, Member State clinical trial authorities and ethics experts, resulting in consolidated written advice

This approach helps reduce fragmentation, anticipate potential regulatory or ethical concerns, and improve the overall quality and acceptability of clinical development plans—particularly in high-priority public health areas.

Regulatory Pharma Net can support Companies throughout the entire EMA scientific advice and SA-CTA request process, including strategic preparation of questions, dossier review, and submission management via the IRIS platform, ensuring an efficient and well-aligned interaction with EMA from early development onwards.