EU Clinical Trials Regulation Is Here

The EU Clinical Trials Regulation (CTR) has been in the works since 2014, but now that it’s actually here, what are the basics you need to know?

The CTR, which went into effect on January 31, 2022, harmonizes the assessment, approval, and supervision of clinical trials throughout the EU via a central database, the Clinical Trials Information System (CTIS). The new Regulation was created to promote clinical research in the EU by streamlining the clinical trial application (CTA) process, while improving transparency on trials by making information accessible to the public.

Under the previous process, known as the Clinical Trials Directive (CTD), running a multi-country trial in the EU meant the sponsor had to send a separate CTA to the competent authorities and ethics committees of each country targeted. Then each country had to authorize the trial based on its own adaptation of the CTD into national regulations, which varied between countries. Inefficient and costly, the process ultimately hindered clinical research in the EU.

Under the new Regulation, sponsors may submit a single CTA through the CTIS, which allows for parallel review by EU/EEA Member States. The CTA is a two-part dossier: Part I involves general information about the trial, and a lead Member State (proposed by the sponsor) coordinates and reports a collective response from contributing Member States; Part II involves country-specific information, and sponsors complete a Part II for each Member State concerned. Within a set timeline, each Member State concerned must notify the sponsor of its decision via the CTIS. 

Transition period for clinical trial sponsors

From January 31, 2022 through January 30, 2023, sponsors have two choices for CTA submission: 

  • Apply using the CTD system, EudraCT (with individual submission for each targeted Member State). Approved trials may follow regulations per CTD until January 30, 2025.
  • Apply using the CTIS (simultaneous submission for up to 27 EU Member States plus Iceland, Liechtenstein and Norway). Approved trials will be immediately governed by the CTR.

Starting January 31, 2023, any sponsor seeking to run an EU/EEA trial must submit a CTA through the CTIS. 

By January 31, 2025, any ongoing trial that had been approved under the CTD must be transitioned to CTIS for governance through the new Regulation.

New considerations for sponsors

The timeline for initial CTA approval ranges from 60 to 106 days under the CTR. However, amendments may not be made until after initial approval is granted. Then, adding a country or clinical site will trigger a new review period. Therefore, sponsors are urged to select countries and clinical sites carefully when planning their submission. 

In addition, since EU countries could have simultaneous approval of Part II, all EU sites could potentially have a shipment request go live overnight, depending on the sponsor’s clinical site initiation policies and IRT management. Sponsors will need to be ready with supply and distribution in place. 

Sponsors may also consider alternate strategies for completing Parts I and II of a CTA. There may be reasons, for example, to submit Part I and Part II sequentially (within a two-year deadline), or to include only some countries in Part II initially, with plans to phase in additional countries. 

Xerimis expertise to help guide sponsors

With the CTR comes much to know about the application process, timelines, record handling, Annex VI (the stricter packaging and labeling laws coinciding with CTR), slightly different Good Manufacturing Practices (GMPs) and more. Xerimis created a webinar explaining key points of the new Regulation and Annex VI. 

For more information on how Xerimis can help your EU clinical trial stay on track, contact us today.