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02-08-2021 14:42 |
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Six-month
countdown to go-live for the Clinical Trials Information System (CTIS) |
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The European Commission has
confirmed that the entry into application of the Clinical Trials Regulation
and hence the go-live date for the Clinical Trials Information System (CTIS)
will be on 31 January 2022. As set out in the Clinical Trials Regulation, the entry into application of that Regulation is set by the publication of a notice in the Official Journal of the European Union [link], which confirms that the clinical trial EU Portal and Database, one of the main deliverables of the Regulation and the key component of CTIS, has reached full functionality. The application of the Regulation and the go-live of CTIS take place six months after the publication of this notice. The Clinical
Trials Regulation aims to harmonise the submission, assessment and
supervision processes for clinical trials throughout the EU. CTIS
will allow the streamlining of these processes, ensuring the EU remains an
attractive region for clinical research. CTIS will
become the single-entry point for clinical trial application submission,
authorisation and supervision in the EU, and in the European Economic Area
(EEA) countries Iceland, Liechtenstein and Norway. Currently, sponsors must
submit clinical trial applications separately to national competent
authorities and ethics committees in each country to gain regulatory approval
to run a clinical trial. With CTIS, sponsors can apply for clinical trial
authorisation in up to 30 EEA countries with a single application. The
Clinical Trials Information System will also, together with other EMA IT tools,
support the coordinated assessment of safety reporting in the context of
clinical trials and therefore contribute to the understanding of the benefits
and the risks of medicinal products that are planned to enter or are already
on the market of the Union. The system
will facilitate recruitment of trial participants by allowing sponsors and
researchers to easily expand trials to other EEA countries, and will support
collaboration across borders for better results and knowledge-sharing. The system
will contain a public website with detailed information on and outcomes of
all clinical trials conducted in the EU, thus improving
transparency and access to information for patients, healthcare workers and
other interested parties. Three-year transition period The
Clinical Trials Regulation foresees a three-year transition period. Member
States will work in CTIS immediately after the system has gone live. For one
year, until 31 January 2023, applicants can still choose whether to submit
their application to start a clinical trial according to the current system
(Clinical Trials Directive) or according to the Clinical Trials Regulation.
From 31 January 2023 onward, submission according to the Clinical Trials
Regulation becomes mandatory and by 31 January 2025, all ongoing trials
approved under the current Clinical Trials Directive will need to transition
to the new Regulation and to CTIS. While the
authorisation and oversight of clinical trials is the
responsibility of Member States, EMA will maintain the system. EMA has
created an extensive training programme to help clinical trial sponsors,
national competent authorities and ethics committees prepare for using CTIS. The
training catalogue consists of several modules, covering the full lifecycle
of clinical trial submission, authorisation and supervision. Modules are
available for use on the CTIS
training programme webpage on the EMA website. The CTIS training
programme webpage is progressively updated as more training materials become
available. EMA has also published a
sponsor handbook to provide clinical trial sponsors with the information
they need to get ready for, and use, CTIS. (MKY) |
