Considerations for sponsors when producing an EU IMPD: Impact of the EU-CTR

picture 11111

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.

How to read this journal article 

Thank you for visiting Regulatory Rapporteur. Journal articles are restricted to registered users and TOPRA members.

Already a member or have an account? Sign in.


Free access to selected content

Register now to continue to access industry news, editorials and podcasts plus one member-only journal article each month.

  • Create your own library to save your favourite content.
Create a free account

2. Members login

Already a TOPRA member?

Log-in now using your MyTOPRA credentials, for unlimited access to all Regulatory Rapporteur journal articles, the online archive and latest industry news and podcasts.



Special offer on
TOPRA membership

Join TOPRA today and get membership until the end of 2025 for the exclusive rate of £290.

In addition to unlimited access to Regulatory Rapporteur content, as a TOPRA member you will also be able to enjoy a wide range of benefits including career boosting resources, savings on our events and training, and access to our regional networks and special interest groups.

This offer ends 31 July 2024

Become a member