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.

 This is member-only content

To read this article, SIGN IN NOW if you are a TOPRA member.


Not a TOPRA member yet? Join our global community.

Five great reasons to become a TOPRA member:

  1. Great savings on our events and training.
  2. Be part of our dynamic international community.
  3. Contribute to the profession.
  4. Grow your skills and knowledge.
  5. Take your career to the next level.

Have you heard what you’re missing? Listen now to the RegRapPod podcast show, for free!