Convergence: EMA official urges transition of existing clinical trials to CTIS portal

MONTREAL – Sponsors should plan to transition existing clinical trials into the new Clinical Trial Information System (CTIS) portal by 30 January 2025, Anabela Marcal, of the European Medicines Agency (EMA), told attendees at RAPS Convergence 2023.

Marcal, who serves at the EMA liaison to the US Food and Drug Administration (FDA), provided an update on the CTIS, along with practical regulatory considerations for planning and conducting clinical trials in Europe
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The CTIS portal, which launched in 2022, replaced the EudraCT portal in January 2023. Clinical trial sponsors are now required to use the portal to apply for authorization to run a new trial. The deadline for transitioning ongoing trials to the new portal is 30 January 2025.

In the meantime, EMA has also released new transparency rules governing the protection of commercially confidential relationships under the Clinical Trials Regulation. These new rules aim to simplify the reporting for CTIS users.

Applications continue to grow

Applications through CTIS are steadily increasing, Marcal said. In 2022, 552 initial clinical trial applications were submitted through the portal. Through mid-September 2023, more than 2,200 initial clinical trial applications have been submitted.

“Every month it is increasing,” she said. “The responses are picking up.”

But the transition of existing trials to the new portal has been slower. To date, just 300 transitional trials have been placed in the portal, out of an estimated 4,000 to 6,000 possible trials. “My message is to do please start as soon as possible. It is not so far away,” Marcal said.

Ensuring a successful submission

Sarah Bly, director of regulatory science, strategy and innovations for Worldwide Clinical Trials, a contract research organization, offered attendees advice on ensuring a successful submission to the CTIS. First, companies should make sure they have the resources to respond quickly to any requests for information from regulators, she said.

“Do be aware, if you are submitting a large study in the EU and you are submitting Part 1 and Part 2 packages at the same time, make sure that you have the resources to respond to questions that come to you at the same time,” Bly said.

Sponsors have just 12 days to respond to questions. If a response is not received during this time, the trial application is deemed to be “lapsed,” she said.

Managing document overload

Ben Kaspar, director of regulatory affairs for MMS Holdings, highlighted the EU’s Clinical Trials Regulation new documentation requirement, including the substantial public disclosure.

Under the new regulations, sponsors must submit two sets of documents in the portal. One set contains proprietary documents that cannot be released publicly, and one set contains non-proprietary information that can be published.

To manage the large volume of documentation, Kaspar recommended that sponsors adopt the use of a “lean authoring” template to ensure smoother reviews by regulators and shorter review timelines. This approach also eases the process for submitting confidential information, he said.

Convergence: EMA official urges transition of existing clinical trials to CTIS portal

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