New implementation date of the Clinical trial regulation | Fieldfisher
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New implementation date of the Clinical trial regulation




The European Medicines Agency (EMA) has just announced that the implementation date of the EU Regulation governing clinical trials (CTR) and the go-live of the centralised portal is scheduled for December 2021. The regulatory audit to check the IT system (CTIS) is planned to start in 6 months, in December 2020. Concretely, sponsors, either commercial or academic, must wait an additional 18 months to use CTIS and run their clinical trials on medicines throughout the EU with the same application file. Procedures, ICF and contracts should thus be adapted.
A launch in December 2021 would mean that it has taken seven years since the publication of the CTR. Amongst others, Brexit, with the EMA move to Amsterdam, and Covid-19, have been the last obstacles delaying the implementation of the regulation and the new system.
The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC). The CTR, when implemented, will lead to greater harmonization of requirements across member states.
Key aims of the new CTR are to harmonise procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submission through a new EU clinical trial database and portal. Together with the submission of a single CT dossier through the EU Portal, the improved assessment process will ensure efficiency of resources for both sponsors and member state sand predictable approval timelines. Unless confidentiality is justified, the information submitted to the EU Portal will be published allowing full transparency of ongoing trials and their results to the public.
Other aspects of the CTR include more detailed safety provision assessments, new indemnity provisions and a category for low interventional trials. The new regulation also intends to make it easier for pharmaceutical companies to conduct multinational clinical trials, which may ultimately increase the number of studies conducted within the EU.
Informed consent will be a significant issue in clinical trials as the CTR requirements are not identical to those introduced in the GDPR, the latter giving enhanced protection to health data. Those undertaking clinical trials will need to review their consent policies against the CTR, reconcile them with their data protection policies and ensure both also meet the requirements of the GDPR.  The extent of the GDPR’s reach to co-sponsors will also need to be factored in alongside the enhanced rights of data subjects to withdraw consent at any time, request deletion of data and the right 'to be forgotten’.
The UK life sciences sector employs around 250,000 people in the UK with 950 clinical trials involving over a million patients in 2018. The CTR is expected to come into force in 2021 - after the Brexit transition period ends. The UK Government has stated that it will align ‘where possible’ with the CTR which is evidenced by Clause 4(1)(a) of the UK Medicines and Medical Devices Bill that explicitly "provides the means for provision to be made which is corresponding or similar to the EU Clinical Trial Regulations, if the Government were to choose to do so". Further, the UK Government is currently planning its own public database to provide UK patients and researchers a single reference point for all UK-based trials.

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Life Sciences