In January 2022, EU (536/2014) – a binding regulation across all members of the EU – came into effect. The new regulation will streamline procedures and remove duplication of single submission via a single EU portal. It also focuses on an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, a greater level of harmonization, and transparency requirements.
For this Clinical Leader Live I spoke to Sylvia Marecki, Marieke Meulemans, Adam Lambert, and Thomas Hagemeijer about the opportunities and challenges of EU (536/2014). In this segment, Marieke Meulemans discusses when full adherence to the regulation will be required and what drug developers can expect in terms of timelines.