The new EU Clinical Trials Regulation came into force in January this year
The new EU Clinical Trials Regulation came into force in January this year. What changes will this bring to the business?
• Centralized application procedures. Applications will now have to be submitted through a single Clinical Trials Information System. The portal allows applying for trial authorizations in up to 30 EEA countries with a single application;
• Increased transparency of clinical trials. All information about the trial becomes publicly available, except for information considered commercially sensitive or confidential;
• Reduced requirements. For low-intervention clinical trials, the application submission and trial participants’ consent requirements are now lighter. The monitoring and basic rules for the clinical trial master file and the release of the investigational medicinal product are less stringent as well;
• Adjustments to timelines for filing applications, conducting trials, and archiving files;
• More detailed requirements for informed patient consent;
• Adjustments to the submission of the information on substantial changes procedure.
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