EU says new trial regulations make region more attractive for studies

The EU says new trial regulations will help harmonize the submission, assessment, and supervision processes of clinical trials conducted in the bloc.

The Clinical Trials Regulation – which “entered into application” last week – will introduce the Clinical Trials Information System (CTIS), a database for sponsors and regulators for the submission and assessment of clinical trial data.

For sponsors, the key benefit will be to facilitate drug studies that take part in several countries in the union according to the EU.

“In the past, sponsors had to submit clinical trial applications separately to national competent authorities (NCAs) and ethics committees in each country to gain regulatory approval to run a clinical trial, and registration and posting of results were also separate processes.

“With CTIS, sponsors can now apply for authorizations in up to 30 EU/EEA countries at the same time and with the same documentation. Publication of the trial information is built in the system.”

The new system will “strengthen Europe’s position as an attractive location for clinical research” according to the EU.

It wrote that, “The aim [of the CTR] is to further develop the EU as a focal point for clinical research, promote the development of high-quality, safe and effective medicines, and to better integrate clinical research in the European health system.”

The EU added that the regulation is also designed to make the results of drug research more accessible.

The EU wrote, “Because transparency is a major feature of the CTR, CTIS also includes a searchable public website, that will prospectively contain detailed information on and outcomes of all clinical trials authorized through the system.”

Transition period

There will be a three-year transition period.

For one year, until 31 January 2023, clinical trial sponsors can still choose whether to submit an initial clinical trial application in line with the current system or via CTIS. After that date the submission of initial clinical trial applications via CTIS becomes mandatory.

And by 31 January 2025, all ongoing trials approved under the current Clinical Trials Directive will be governed by the new Regulation and have to be transitioned to CTIS.

The authorization and oversight of clinical trials is the responsibility of EU and or EEA Member States while the European Medicines Agency (EMA) is responsible for maintaining CTIS.

Image: Stock Photo Secrets