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Are you ready for the new EU Clinical Trials Regulation?

January 28, 2022

The new Clinical Trials Regulation, which goes live on 31 January 2022, will harmonise and digitise drug trials across Europe. What does it mean for life science businesses?
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The Regulation marks a major change in the way clinical trials are carried out.

All trials for new medicines hosted within the European Economic Area (EEA) will be processed, assessed and supervised through a new portal, called the Clinical Trials Information System (CTIS).

CTIS replaces member country systems. It is designed to standardise the data submission process and make trial data more accessible and transparent by digitising it in one central source.

Submissions will be made and assessed centrally on the CTIS and a single approval decision will be made for the whole of the EEA at the end of each trial.

CTIS is designed to standardise the data submission process and make trial data more accessible and transparent by digitising it in one central source.”

Edward Hunter | Life Sciences Broking Leader
Global Markets Direct & Facultative, WTW

Businesses involved in clinical trials have a year’s transition time to start using CTIS and trials already underway will have three years to migrate their data.

Implementation timeline

  • 31 January 2022: the Regulation comes into effect; CTIS goes live.
  • 31 January 2023: all new applications for clinical trials must be submitted via CTIS.
  • 31 January 2025: all ongoing clinical trials must have transferred into CTIS.

What’s behind the change?

The EU has been aiming to standardise the clinical trials process since 2014 but implementation was delayed pending the development of CTIS.

The main aims of the Regulation are to:

  • simplify submission and assessment for trials carried out in multiple member states
  • reduce delays and red tape in decision making
  • make trial data available for future analysis, for example to find new purposes for existing drugs as happened during the pandemic
  • improve collaboration, information sharing and decision making among clinical trial stakeholders and between member states.

The system could also increase recruitment to trials by enabling companies to easily expand trials to sites in other EU countries.

Does the Regulation apply in the UK?

No, the Regulation does not apply in the UK. When the UK left the EU it also left the EEA and the European Medicines Agency, which governs the new system. Companies carrying out trials that span the UK and EEA countries will need to meet different requirements.

How could the new Regulation affect your risk profile?

CTIS will make all data from trials hosted in the EEA available to members of the public.

Companies can apply for exemptions for commercially confidential information.”

Edward Hunter | Life Sciences Broking Leader
Global Markets Direct & Facultative, WTW

Companies can apply for exemptions for commercially confidential information.

However, this will not be granted if there is an overriding public interest.

It’s possible that more information than was previously in the public domain will be released where there is a public interest, for example related to adverse events during trials.

This has the potential to increase exposure to liability for companies and directors if they failed to act on such data.

Any questions?

Please get in touch if you’d like to find out more about the changes and how they could affect you.

Contact

Edward Hunter
Life Sciences Broking Leader
WTW

Edward joined WTW in October 2005. His focus is on all aspects of brokerage services and placements within the London and international markets for a variety of casualty programs. Within that role Edward also leads the Global Markets P&C Hub's Life Science Practice. He has gained an excellent knowledge of the London marketplace and developed relationships with UK, US, European and Bermudan underwriters. Edward has more than 16 years of experience in marketing, broking and placement in respects to US, UK and international liability programs.


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