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.
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:
The system could also increase recruitment to trials by enabling companies to easily expand trials to sites in other EU countries.
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.
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.
Please get in touch if you’d like to find out more about the changes and how they could affect you.
