The "Questions and Answers document" in the EudraLex volume 10 on clinical trials has been revised. The revised version 4.0 of this document is available here.
New are the Questions 3 and 4 and their respective answers:
- Question 3: Is an authorised medicinal product used as comparator in a clinical trial an investigational medicinal product?
This question is answered with a clear "yes":
"According to Article 2(d) of Directive 2001/20/EC, an investigational medicinal product (IMP) is "a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial […]". Comparators are medicinal products used as a reference in a clinical trial vis-à-vis the substance being tested. The definition of IMP in Article 2(d) of Directive 2001/20/EC clarifies further that it "includes" "[…] products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form". This is intended to clarify what the definition entails. It does not mean that a non-modified medicinal product with a marketing authorisation is not an IMP. The purpose for the inclusion of comparators into the definition of IMP is that they play a fully equivalent, symmetric, role as counterparts to the "tested products", and this from the inception of the protocol to the interpretation of the study results. The comparator is an IMP and the conditions (circuit, traceability and accountability methods) under which the comparator is used are to be strictly the same as those of the tested product."
- Question 4: What can be considered a "non-interventional trial"?
The answers to the following questions have been revised:
- Question 8: Can the sponsor delegate tasks or responsibilities?
- Question 18: Can the dates of the annual safety reports be aligned with other periodic reporting requirements?
On the behalf of the European Compliance Academy (ECA)
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