Europe – EC updates Clinical Trial Regulation Q&As ahead of January go-live

The European Commission has issued an updated question-and-answer guidance clarifying certain aspects of the Clinical Trials Regulation (CTR), which is set to go into effect this January.

The revision clarifies that active pharmaceutical ingredients (APIs) used in investigational medical products do not have to comply with good manufacturing practices (GMPs) in the clinical trial application, describes the content of the protocol synopsis, and adds a new question on how sponsors should report the dates that annual safety reports (ASRs) are to be submitted for investigator-initiated trials.

The updated version of the question-and-answer document replaces the previous version issued in July, and is being issued ahead of the 31 January 2022 full launch of the CTR. The new regulation will replace the clinical trials directive, which has been in place since April 2001…