October 2021: EU Regulatory Update

The European Commission (EC) made available the Draft – Questions and Answers Document – Clinical Trials Regulation (EU) 536/2014 – Version 4.1 (September 2021) on October 14, 2021. This is not a final version and updated versions of the Q&A will be published progressively.

The questions and answers that are added or revised in this version are: 5.8, 7.39 (new), 8.4, annex II

  1. Section 5.8: This section has been updated to include more general information regarding protocol synopsis to be submitted with the clinical trial application according to Annex I D24
  2. Section 7.39: This has been added newly to provide information regarding anticipated date of annual safety report (ASR) submission under specific condition
  3. Section 8.4: Modified to include an additional point for information regarding the good manufacturing practice (GMP) compliance of the active pharmaceutical ingredients
  4. Annex II: Language requirements for part I documents was modified

Section 6 deals with submission of the results, and it is not affected by the current revision.