EFPIA update on the readiness for mandatory use of the Clinical Trials Regulation

Today (31st January 2023) marks the start of the mandatory application of the Clinical Trials Regulation for all new clinical trials. It is a significant milestone in the transformation of the oversight and management of clinical trials in the EU. EFPIA would like to acknowledge and thank the EMA, Member States and the European Commission for the extensive work carried out to reach today’s landmark moment.

EFPIA members have been working hard to ensure that they are fully prepared and ready to meet the requirements of the new Regulation.

A majority of EFPIA members have already submitted at least one clinical trial application through the Clinical Trials Information System (CTIS), the electronic system underpinning much of the operational aspects of the Clinical Trials Regulation.

Additionally, several companies have gained greater experience by submitting multiple applications and using the CTIS to manage interactions with Member States during the conduct of their clinical trials.

During this first year of operation of the Clinical Trials Regulation, most clinical trial applications completed the approval process successfully. There have been some initial problems, mostly minor and quickly resolved; however, some issues have required extensive work to achieve a resolution.

EFPIA is grateful for the intensive work undertaken by EMA over the past year to address significant issues which would have hindered or blocked processes in CTIS.

We would urge to now focus on further developing and enhancing the usability and functionality of the system necessary for the effective conduct of clinical trials and for the EU to remain attractive for clinical research.

EFPIA is also aware of a number of issues around the implementation of the Clinical Trials Regulation itself that need to be addressed. In particular, the lack of alignment regarding Member State requirements for the assessment of Part II aspects, and situations where Member States are taking different approaches to reviewing trials that need to be transitioned from the previous legislative regime to the Clinical Trials Regulation.

With a large number of transition trial applications yet to be submitted, a simple and fast approval process that allows these previously approved and ongoing trials to transition to the new legal framework without any reassessment, is needed.

These are early days for CTIS and the application of the Clinical Trials Regulation. EFPIA continues to believe that both will play their part in making the EU a competitive location to conduct clinical research. We also believe that it will remain key for the EMA and the Commission to continue to meet with sponsors, Member States, and other stakeholders on a regular basis to allow for the sharing of comments and concerns and to discuss progress, issues, and future needs.