EMA adds Disclaimer to the Reflection Paper on the Use of IRTs

Recommendation

15/16 November 2023

Serialization/Aggregation - Live Online Training
Requirements, Challenges & Solutions

The European Medicines Agency (EMA) added a disclaimer to the Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates to address its applicability regarding the European Clinical Trials Regulation (CTR). The reflection paper still reflects the state of thinking at the time of initial publication, and is applicable for trials authorized under the Clinical Trial Directive (CTD). It has not been reviewed and revised to take into account the CTR. However, it should be noted that in line with the CTR and the Commission Delegated Regulation (EU) 2022/2239 of 6 September 2022 amending the CTR as regards labelling requirements for unauthorized investigational and unauthorized auxiliary medicinal products (IMPs / AxMPs) for human use, the expiry date can be omitted only from the inner packaging and in specific cases. For additional information on requirements for IRTs, please refer to the Guideline on computerised systems and electronic data in clinical trials.

For more detailed information please see EMA´s Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates published on EMA´s GCP Inspectors Working Group website.