Instead of needing both National Competent Authority (NCA) and Ethics Committee (EC) approvals, EU-CTR enables a single NCA and EC decision per member state.įor multinational applications, a co-ordinated assessment will be led by one reporting member state throughout a trial’s life cycle. While the type of information required for clinical trial applications remains the same, the submission process has been refined to co-ordinate and harmonise assessments of multinational applications. At a basic level, though, seven changes from EU-CTD are essential to understand:ġ. Most sponsors would benefit from thorough EU-CTR training. EU-CTR is here to stay, so sponsors must think carefully about the right time to transition and their optimal transition strategy. 31 January 2025 onward: all clinical trials must be regulated under EU-CTR.ĮU-CTR applies to trials conducted in single or multiple EU member states, and authorities plan to review it every five years to ensure it achieves its intended results.However, trials approved under EU-CTD before 31 January 2023 can continue to be regulated under EU-CTD until 31 January 2025. ![]()
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