Questions and Answers on Clinical Trials Regulation (EU) No 536/2014 Update (December 2022)

On December 22, 2022, the European Union (EU) posted a document titled Questions and Answers Document – Regulation (EU) 536/2014 – Version 6.3.

The document provides thorough responses to all queries regarding Clinical Trials Regulation (EU CTR) No. 536/2014, including those pertaining to the Regulation’s scope in the EU, its application procedure, substantial modifications, withdrawals, roles, clinical trial submission, start, end, temporary halt, and early termination, transitional period, informed consent, and other substantial modifications.

Sections 1.4 (updated), 3.8 (updated), 11.7 (updated), 11.16 (updated), and Annex III (new) are those that are added to and updated in this version in relation to clinical trial transparency.

  • Section 1.4: The Clinical Trials Regulation (EU) 536/2014 and the Questions and Answers documents available on Eudralex volume 10 have been updated to add more information on Annex III, which states that the national competent authorities may not respond to inquiries for which information is already available.
  • Section 3.8: Updated with details on reference document uploading during the first clinical trial application submission.
  • Section 11.7: Updated by providing details about the prerequisites for uploading additional documents, if any are available, in addition to the required documents. If a sponsor is unable to supply a specific document listed in Annex I, they must submit one that clarifies the NCA’s and/or ethical committee’s favorable assessment of the clinical trial under CTD. After the transition application’s approval, this replacement document will be included in the first application as a substantial modification.
  • Section 11.16: Updated to reflect the requirement for sponsors to mention in the cover letter that all transitioned documents, including those that will be transitioned, have received prior clearance from all MSCs.
  • Annex III: This section was recently added to include websites with links that sponsors can use to find crucial information before submitting Part II documents as part of their clinical trial applications. It also includes email addresses for sponsors to contact with questions about Part I and Part II clinical trial applications.