The new EU Clinical Trial Regulation is going live in December 2021
– And enables several benefits for your organization for the CTA submission process.
The new Clinical Trial Regulation focuses on facilitating the Clinical Trial Application (CTA) process across all the EU Member States by streamlining submissions and approvals. The European Medicines Agency (EMA) has recently announced that the Regulation will Go-Live in December 2021. The organizations interested in performing clinical trials in EU must get ready for the changes associated with the implementation of the new Regulation.
The Clinical Trial Regulation 536/2014 replaces the Clinical Trial Directive 2001/20/EC aiming to power a collaborative clinical trial environment in EU.
The application of the new Regulation depends on the full functionality of the Clinical Trial Information System (CTIS). This electronic platform acts as a portal to submit and manage CTAs and safety reports and establish communication with Member States during the evaluation of the application. CTIS also acts as a database where clinical trial data and non-confidential information about clinical trials is stored and can be freely accessed in the future by anyone.
The new Regulation is based on three fundamental pillars:
- Harmonization of the CTA process across all EU Member States due to the submission of a single e-dossier via CTIS. Part I of the dossier will be evaluated collaboratively by all Member States Concerned (MSC) reducing the scientific assessment of the application to only one. Part II of the dossier is evaluated individually by each MSC, National Competent Authority (NCA) in collaboration with the national Ethic Committee (EC), resulting in one single and unique approval decision per MSC.
- Public disclosure of clinical trial information to increase transparency and generate trust. Sponsors should submit a summary of clinical trial results to the EU-database via CTIS within one year from the end of the trial in all MSC.
- Simplified safety reporting requirements to ensure the highest safety standards. Annual Safety Reports are submitted via CTIS but Suspected Unexpected Serious Adverse Reactions (SUSARs) and Development Safety Update Reports (DSURs) are still submitted via EudraVigilance database.
EU Member States will be ready to receive CTAs via CTIS from the day the Regulation becomes applicable, but your organization has a three-year transition period. During the first year of transition, new CTAs can be submitted via CTIS or under the Clinical Trial Directive. During the second- and third-year new CTAs must be submitted via CTIS. By the end of the transition period, ongoing clinical trials authorized under the Directive must have switched to CTIS.
The implementation of the Regulation will affect your organization.
It addresses multiple capabilities across trial planning, execution and reporting. Therefore, changes in people, in terms of roles, responsibilities and training, mindset, processes and data systems are required. You should consider this change as an opportunity for standardization and process optimization in terms of CTA and inspection readiness. You can definitely benefit from the new Regulation that is about to become applicable if adapted correct.
Are you ready for the new EU Clinical Trial Regulation?
We can ensure that you reap the benefits of the new regulation so that it does not just become a cost.
We can help analyze clients current state, identification of gaps and supporting the planning and implementation to close the gaps.
We can assist you by combining a proven life science methodology with a “best-in-class” knowledge of the clinical trial area.
Allan Bech Thomsen
Senior Project Manager
Allan is a high-performance senior project manager, specializing in Program/Project Management, Program/project Execution, Change Management, Business & IT Strategy Alignment and Financial Management. Allan has been working in the Information Technology space for the last 30 years.