European Medicines Agency Issues Guidance on Single-Arm Trials for Drug Approval

The European Medicines Agency has released a reflection paper on using single-arm trials (SATs) as pivotal evidence in marketing authorization for medicines in the EU. The document, which followed a public consultation, outlines the key considerations and methodological requirements for SATs when submitted as primary evidence in support of drug approval applications. It focuses on aspects unique to SATs and aims to guide both applicants and regulators in assessing their suitability for regulatory decisions. The paper was adopted by the Committee for Medicinal Products for Human Use (CHMP) with input from related committees, including those for advanced therapies and oncology.¹

Read more here.

References

1. Establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation | European Medicines Agency (EMA). (n.d.). European Medicines Agency (EMA). https://www.ema.europa.eu/en/establishing-efficacy-based-single-arm-trials-submitted-pivotal-evidence-marketing-authorisation

Disclaimers

• The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
• Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
• No official support by any organization(s) has been provided or should be inferred

Recommended Reads

• EMA news: Establishing efficacy based on single-arm trials in marketing authorisations
• India’s ascendancy in 2023
• EMA recommends first vaccine to protect older adults from RSV
• Is There a Benefit to the Covid-19 Pandemic?
• COVID-19 Vaccine Development and Testing at a Record-Setting Rate