Interesting Nugget in EU CTR Q&A

The European Commission has issued several versions of a Q&A document addressing the implementation of the Clinical Trials Regulation (EU) No. 536/2014 (EU CTR). Deep into Version 6.1 (May 2022) of the EU CTR Q&A, we found the response to Question 7.47 very thought provoking.

Question 7.47 reads “What are the general rules for reporting safety of auxiliary medicinal products (AxMPs)?” While the majority of the answer relates to the reporting of serious adverse events (SAEs) attributed to AxMPs, the following statement is at the end of the response: “Safety measures should be taken also due to ASRs (Annual Safety Reports) of AxMPs in the trial (i.e., protocol modified, as needed).”

The EU CTR describes AxMPs as products used in “the context of a clinical trial as described in the protocol for background treatments, as challenging agents, rescue medication or to assess the end-points.” While most companies monitor the safety profiles of innovators, comparators or products in the same drug class as the investigational product to assess impact on study conduct, are companies regularly monitoring the safety of AxMPs?

A change in the safety profile of an AxMP could impact trial participant safety. Companies should incorporate safety monitoring of AxMPs into their signal management activities. Monitoring can consist of reviewing regulatory websites (FDA, EMA, WHO) and product labeling (innovator or specific product in the protocol) to identify changes in the safety profile. Decisions regarding impact on the protocol and patient safety should be documented.

I know… One more thing to monitor…

If you have questions or would like to discuss further, please contact me.

Jennifer True jentrue@jpccassociates.com

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