Single-arm trials as pivotal evidence for the authorisation of medicines in the EU

21 April 2023 – The European Medicines Agency (EMA) has opened a public consultation on a reflection paper that discusses key concepts for single-arm clinical trials that are submitted as pivotal evidence in support of marketing authorisation applications for medicines in the EU. This is the first guidance document by an international medicine regulator articulating the considerations and challenges associated with this type of clinical trials. Stakeholders are invited to send their comments via an online form by midnight (CET) on 30 September 2023.

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