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Pharma IT Insights
5 Considerations for Ensuring EU Clinical Trials Regulation (CTR) Readiness
By Maria Iversen
May 31, 2022
Pharma IT Insights
5 Considerations for Ensuring EU Clinical Trials Regulation (CTR) Readiness
By Maria Iversen
May 31, 2022
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The EU’s new Clinical Trials Regulation (CTR) is live! In this Insight, Principal Consultant Maria Iversen briefly describes the regulation’s purpose and provides five considerations for sponsors conducting clinical trials in the EU.
The new EU pharmaceutical legislation, known as the Clinical Trials Regulation (CTR), entered into application on 31 January 2022. If you currently operate or plan to operate clinical trials in Europe, you will be impacted by the CTR[1].
While CTR aims to simplify and harmonize the regulatory landscape for conducting clinical trials in Europe, it also brings additional requirements and challenges for sponsors. There is a transition period until 31 January 2023, in which sponsors should become aware of these requirements and prepare to implement the necessary changes.
To assist you in this process, we have collated the top 5 changes that you should be mindful of as a sponsor when conducting clinical trials in Europe.
#1 Increased public disclosure requirements for sponsors’ clinical trial details
The CTR aims to provide more transparency on clinical trial data. Consequently, information submitted to the recently launched Clinical Trials Information System (CTIS)[2] will be publicly accessible unless its confidentiality can be justified. Sponsors are thus obliged to redact documentation containing personal and/or corporate confidential information before submitting documents in CTIS.
The redaction may impact most of the submission documents throughout the conduct of a clinical trial and will be a comprehensive task. Sponsors are therefore encouraged to create a redaction strategy and ensure resource allocation in due time.
#2 Reduced flexibility in substantial modifications
Under CTR, substantial modifications will take up to 69 days to be reviewed and approved. No additional substantial modifications can be submitted until approval/rejection has been received. This also includes the addition of new European countries to the trial scope and may impact country selection strategies and the timing of transfer of ongoing trials to CTR.
#3 New clinical trial supplies requirements
CTR introduces new packaging/labeling requirements. The expiry date is now required on the inner packaging. Further, for blinded clinical trials, the name of both the IMP and comparator/placebo must appear on the label. Additionally, labels should be added to authorized Auxiliary Medicinal Products (as per the new definition of Auxiliary Medical Product by CTR).
#4 Safety Reporting Requirements
For clinical trials authorized under CTR, sponsors must report Unexpected Events, Urgent Safety Measures, Serious Breaches, Annual Safety Reports in CTIS. Suspected unexpected serious adverse reactions (SUSARs) must be reported to EudraVigilance.
#5 Strict Timelines
Under CTR, the maximum response time for a Request For Information (RFI) is 12 calendar days. Failure to comply with these timelines will result in withdrawal in all Member States Concerned. RFI will only be available through the CTIS, which means close monitoring of potential updates in CTIS is required.
Need CTR assistance?
If you could benefit from assistance with CTR compliance, do not hesitate to reach out to the Pharma IT team.
Click below to get in touch.
Need CTR assistance?
If you could benefit from assistance with CTR compliance, do not hesitate to reach out to the Pharma IT team. Click below to get in touch.
There are several questions that may arise in your organization concerning the impact of the new CTR
At Pharma IT, we have experience assisting our customers with ensuring their current and future clinical trial strategy has incorporated the changes necessitated by the new CTR. We suggest all organizations begin by taking a moment to think through the following:
- What is the key focus for your company right now?
- What is mandatory for sponsors and what can be outsourced?
- How will CTR impact your SOPs and processes?
- Which clinical trials are in scope and what will the impact be?
- Which IT systems may be impacted?
If you could benefit from further assistance understanding and planning for, or ensuring CTR compliance, do not hesistate to reach out to the Pharma IT team. Our consultants are ready to help you with any questions that you may have.
Sources cited
[1] EudraLex Vol. 10 – Clinical trials guidelines: EudraLex – Volume 10 (europa.eu)
[2] Clinical Trials Information System (CTIS) – Sponsor Handbook: CTIS Sponsor Handbook 2021 (europa.eu)
About the author(s)
Maria Iversen is a Principal Pharma Consultant with 13 years of experience as a global trial manager, working with phase I, II, III and IV studies from protocol development to finalization of the clinical study
report. She is a subject matter expert in Lab set up and collaboration, sponsorship transfer, vendor management and clinical study reports. Maria has experience with multiple indications with key disease areas being oncology and metabolism.
