Europe – EC Offers Further Clarity on Clinical Trial Regulation

The European Commission (EC) recently updated guidance on the incoming clinical trials regulation, with new questions and answers (Q&As) on requests for information (RFIs), how assessment reports will be made public and the sponsor’s responsibilities regarding changes to a clinical trial that are not substantial modifications but are relevant for supervising the trial.

On the question (number 2.7) of the management of a request for information during the initial assessment of a trial application or the assessment of an application for a substantial modification, the Q&A says: “Sponsors shall submit the requested additional information within the period set by the Member State which shall not exceed 12 days from the receipt of the request of the reporting member state.”

If no information is provided, the application “shall be deemed to have lapsed.” The Q&A also explains how only one RFI will be feasible during the assessment period, so it should focus only on critical issues…