European Union (EU) pharmaceutical legislation – known as the Clinical Trial Regulation (EU-CTR), came into effect on 31 January 2022. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a wider scale, with high standards of public transparency and safety for clinical trial participants.

A predominant challenge that is frequently observed in the construction of the investigational medicinal product dossier (IMPD) is that recommendations provided in the EU-CTR and applicable EMA guidelines, European Pharmacopoeia (Ph. Eur.) monographs and European Directorate of the Quality of Medicines (EDQM) standard terms database may not be taken into consideration. Therefore, non-compliance with EU requirements means that validation queries and requests for information (RFIs) are raised during the review of the clinical trial application (CTA).

The aim of this article is to provide key awareness and guidance on IMPD requirements for sponsors planning to submit CTAs via the EU-CTR. Potential challenges are outlined.