Questions and Answers on Clinical Trials Regulation (EU) No 536/2014 Update (February 2023)

On February 24, 2022, the European Union (EU) posted a document titled Questions and Answers Document – Regulation (EU) 536/2014 – Version 6.4.

The comprehensive responses within the document address all inquiries related to the Clinical Trials Regulation (EU CTR) No. 536/2014. This includes a wide range of topics such as the scope of the regulation within the EU, the application procedure, substantial modifications, withdrawals, the roles of individuals involved, clinical trial submission, start and end procedures, temporary halts and early terminations, the transitional period, informed consent, and any other significant modifications.

This document version includes clinical trial transparency updates to Sections 6.5, 11.6, 11.7, 11.9, and Annex II.

  • Section 6.5 now includes an explanation for why deferrals and redactions cannot be used simultaneously to protect confidential commercial information (CCI).
  • Sections 11.6 and 11.7 have been updated to provide guidance on submitting additional documents for transitioning clinical trial applications. If no additional documents are available, sponsors must upload a document stating that this aspect was assessed by the National Competent Authority (NCA) and/or Research Ethics Committee (REC), and is covered by the conclusion of the assessment under the Common Technical Document (CTD).
  • Section 11.9 now includes information on the authorization of substantial modification documents.
  • Annex II has been updated to include new language requirements for protocol synopsis, patient-facing documents as part of the protocol, labeling, and fields of the application form specifically for clinical trials in France.