Accelerating Clinical Trials in the EU (ACT EU)
Freyr Global Regulatory Affairs
Regulatory Assessment, Market Authorizations, Post-Approval Changes, HA Query Management.
The European Commission (EC), the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) have transformed the way how clinical trials are designed and run in the EU. The latest initiative is taken with an aim to ensure that the medicines under development are safe, efficacious, and of better quality. The Accelerated Clinical Trial Committee (ACT) listed ten (10) actions to be taken on priority which include innovative trial methods, establishing a multi-stakeholder platform, and supporting the modernisation of Good Clinical Practice (GCP).
The Clinical Trial Regulations focus on maintaining the integrity of data expected by the EU citizens while strengthening the European environment of clinical trials.
For compliance best practices, reach out to a proven Regulatory expert like Freyr. https://www.freyrsolutions.com/clinical-trial-and-consulting-services