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European Commission Updates Q&A on EU Clinical Trials Regulation

  • 19/10/2021
  • Articles

On 18 October 2021, the European Commission published in Volume 10 (“Clinical trials guidelines”) of EudraLex an updated version of its Q&A document on the EU Clinical Trials Regulation (i.e., Regulation (EU) No 536/2014 of 16 April 2014 – the CTR).
The updated Q&A document replaces the previous version issued in July 2021. The document: 

  • provides additional guidance on the content and way of submission of the protocol synopsis as referenced in Annex I, point D.24 of the CTR (see, updated answer to question 5.8); 
  • clarifies how sponsors should determine and report the anticipated submission date of the annual safety report (see, answer to new question 7.39); 
  • clarifies that “[i]nformation regarding the [good manufacturing practice] compliance of the active pharmaceutical ingredients is not required by the CTR (and can therefore not be required by the Member States Concerned)” (see, updated answer to question 8.4); and 
  • is accompanied by an updated Annex II (“Language requirements for part I documents”). 

The CTR will enter into force on 31 January 2022 (see, Van Bael & Bellis Life Sciences News and Insights of 22 April 2021, 9 August 2021 and 11 October 2021). It provides for a three-year transitional period during which clinical trials will be gradually transitioned into the CTR system. By 1 February 2025, all clinical trials will be governed by the CTR, regardless of their submission date.  


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