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EC Offers Further Clarity on Clinical Trial Regulation

Posted 12 November 2019 | By Zachary Brennan 

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.

On the question (2.8) of making clinical trial assessment reports public, the Q&A explains how the regulation is meant to increase transparency on trials in the EU, but sponsors can request deferrals from making public some trial information.

“The assessment report is in principle made public at the time of decision, but the moment of publication can be deferred if the sponsor has requested a deferral at the time of the initial submission,” the Q&A says.

If the deferral is agreed to by the member state, the sponsors can “define the timing for the deferral of the publication of the assessment report for the part of their concern.” And member states “will gain a view-only access to the conclusion and assessment report part II from the other Member States concerned as soon as they submit their conclusions for part II to the sponsor even before a decision is notified by these Member States," the Q&A says.

And on the question (3.3) of a sponsor’s responsibilities regarding changes to a clinical trial that are not substantial modifications, but are relevant for the supervision of the trial, such changes “shall be permanently updated in the EU database by the sponsor.”

Sponsors “can always provide non-substantial changes as part of an application for a substantial modification (part I only, part II only or part I and part II) whenever the scope of the non-substantial changes matches with the scope of the application under evaluation,” the Q&A notes.

But the EC also says sponsors are encouraged not to submit non-substantial changes during the RFI phase of any ongoing assessment unless required as part of the RFI response.

The latest version of the Q&A also includes three revised questions.

The EU’s clinical trial regulation was adopted and entered into force in 2014, but its application is contingent on a functional Clinical Trials Information System, which is determined via an independent audit. According to a European Medicines Agency (EMA) update last month, an operational assessment of the system “to identify critical business blockers” still needs to be carried out in order to enable EMA's Management Board to consider the timing of the audit.

CLINICAL TRIALS REGULATION (EU) NO 536/2014 DRAFT QUESTIONS & ANSWERS VERSION 2.2

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