The new Clinical Trial Regulation (CTR) has brought the most significant change to the regulatory landscape in decades, and its introduction affects virtually every aspect of clinical trial operations.
The new regulation offers many advantages to drug developers as it is set to simplify and streamline the work they need to do to stay compliant. Additionally, it’s designed to drive efficiency, improve transparency and increase the safety and efficacy of drugs approved in the EU.
However, the changes are bringing new challenges for companies and sponsors looking to trial drugs in the region. During the current period of change and transition, many are choosing to work in partnership with regulatory consultants like MWB Consulting to manage change effectively and avoid delays and possible penalties.
This article offers an overview of the changes brought in by the European Medicines Agency (EMA) under the Clinical Trials Regulation, what these mean for developers and drug sponsors, and how working in partnership with regulatory strategy consultants can help secure ongoing success.
Overview of CTR changes
The CTR replaced the previous Clinical Trial Directive (CTD) in January 2022, with a full implementation deadline established by the EMA for ongoing trials of 30 January 2025.
These changes are designed to harmonise the assessment and processes for clinical trials on medicinal products for human use in the EU. This should make it easier for drug sponsors to conduct multinational clinical trials, and it’s hoped this will help the region become more competitive and increase the number of studies conducted there.
It brings in a single-decision assessment procedure and new rules on the protection of subjects and informed consent. Additional changes established by the EU CTR include:
A new authorisation procedure based on a single submission via one portal and database
The portal – the Clinical Trials Information System (CTIS) – became the single entry point for data and information submission in 2022, and all new and ongoing trials must be entered into the system by 2025.
Developers now only need to submit one application for all EU countries in which they want to run a trial. Regulators in different countries can review the application together in one system, and the public can look up information about clinical trials happening in the EU.
New transparency requirements
This new database ensures all information held on clinical trials is publicly accessible unless developers can justify a need for confidentiality. Additional revised transparency rules came into effect in June 2024 to further reduce complexity and clarify confusion.
Simplified safety reporting
Clinical trial plans can now specify which side effects need to be reported. Minor side effects that aren’t relevant to a study may not need to be flagged. Separate safety reports are no longer required when testing multiple medicines in a single trial – one report can be submitted that covers all medicines. Additionally, serious and unexpected problems that might be caused by the drug being tested need to be reported in the EudraVigilance database.
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Let’s TalkWhat the CTR means for developers and drug sponsors
In time, these changes should make the regulation landscape easier to navigate. However, in the short-term, they will require developers to master new processes, train staff and get to grips with a host of new requirements quickly to avoid slowing down any ongoing or new trials.
In response to EU CTR, developers have had to manage wide-ranging changes, including:
- Replacing established submission workflows with new CTIS procedure
- Updating documentation management to meet new transparency requirements
- Redesigning safety reporting to ensure they remain compliant
- Understanding new document specifications and enhanced requirements
- Implementing new processes for new trials while transitioning ongoing trials
- Managing changes across multiple departments and locations
- Coordinating and scheduling changes to hit deadlines and avoid potential penalties
Change takes time to become familiar and legislation will continue to present new challenges through to the final transition deadline and beyond.
Developers who are new to or less familiar with the EU regulatory landscape, have smaller teams, or limited resources face a number of additional challenges when it comes to fulfilling their new obligations. These might include:
- Limited internal expertise and a need for dedicated personnel
- The disruption caused by assigning and bedding in new roles and responsibilities
- Additional workload, budget and training requirements
- New obligations taking resources away from ongoing trials and existing work
- More demands on IT to ensure integration with legacy systems
- Delivering multiple language requirements
The benefits of regulatory strategy consulting
In light of the various challenges the EU CTR poses, many start-ups and small or medium-sized pharmaceutical companies are choosing to partner with regulatory consultants like MWB Consulting to manage ongoing change and create an effective strategy for regulatory compliance.
At MWB Consulting, we have a strong track record of meeting and overcoming regulatory challenges and the new Clinical Trials Regulation is no exception. Our team of industry experts have in-depth knowledge of new EU regulations and understand the implications of these new rules for your business. We can provide regulatory advice and help your team get to grips with these wide-reaching changes. We’re also well informed about the details and can help you navigate the updated submissions system, prepare and draft documentation including study designs, and prepare for and/or attend meetings.
We understand that regulatory changes can feel daunting – we’re here to help you navigate every step of the process.
Need help with EU CTR changes?
Contact us today for an initial, free-of-charge discussion with a senior consultant about your project.
Let’s Talk