THE EUROPEAN COMMISION PUBLISHED AN UPDATED GUIDANCE FOR CLINICAL TRIAL REGULATION.
The European Commission published an updated question-and-answer guidance clarifying certain aspects of the Clinical Trials Regulation (#CTR).
This is planned for a full launch on 📆 January 31, 2021. The new regulation will replace the clinical trials directive.
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.
