European Commission Updates Q&A on EU Clinical Trials Regulation
- 02/10/2023
- News
On 29 September 2023, the European Commission published a newly updated version of its Q&A on the EU Clinical Trials Regulation (i.e., Regulation (EU) No 536/2014 of 16 April 2014; the CTR).
The updated Q&A forms part of Volume 10 (“Clinical trials guidelines”) of EudraLex, the collection of EU rules governing medicines, and includes the following changes:
• Point 102 on conditions was revised to clarify that no clinical trial can start (i.e., unless defined differently in the protocol, recruit the first potential subject) unless and until the clinical trial application has been assessed and found to have a positive benefit-risk balance at the time of the authorisation. The updated Q&A adds that “[e]xceptionally, the sponsor must first fulfil a condition within a defined deadline described in the condition text, e.g, in an approved substantial modification application, which could mean that the start of the trial or the inclusion of the first subject is delayed until the condition is met”.
• A new question 7.51 was added which clarifies that, although the CTR does not specify any documentation regarding exposure to ionising radiation in clinical trials, the sponsor is expected to include information on exposure to ionising radiation in the protocol in line with CTR Annex I, section D to allow assessment of the clinical trial’s benefits and risks. The specifics of the information to be included depend on whether the procedures concerned are radiodiagnostic (i.e., radiology and nuclear medicine) or radiotherapeutic (i.e., external beam radiotherapy, brachy therapy and systemic radiation therapies with radiopharmaceuticals). The updated Q&A describes the principles and assessment criteria applicable to both types of procedures and notes that any deviations from the described principles should be justified in the protocol to assess the benefits and risks.
• The answer to question 9.4 was complemented with practical guidance on how to implement Article 32(3) CTR which provides that “[i]f during a clinical trial […] [a] minor reaches the age of legal competence to give informed consent as defined in the law of the Member State concerned, his or her express informed consent shall be obtained before that subject can continue to participate in the clinical trial”.
A copy of the updated Q&A is attached.
