The implementation of the new European Union Clinical trial Regulation | Fieldfisher
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The implementation of the new European Union Clinical trial Regulation


Spain, United Kingdom

The regulation of clinical trials across the European Union (EU) will undergo significant changes when the Clinical Trials Regulation (Regulation (EU) No 536/2014) (CTR) comes into application on 31 January 2022.

The Regulation will repeal the existing EU Clinical Trials Directive (EC) No. 2001/20/EC and national legislation put in place to implement the Directive. It will also apply to trials authorised under the previous legislation if they are still ongoing three years after the Regulation has come into operation.

Key aims of the Regulation is to harmonise the submission, assessment and supervision processes for clinical trials in the European Union (EU) via is the new Clinical Trials Information System (CTIS). CTIS is a single entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data, which includes a public searchable database for healthcare professionals, patients and the public. 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 states and 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. Under the Regulation the authorisation and oversight of clinical trials remains the responsibility of Member States, with European Medicines Agency (EMA) managing CTIS and supervising content publication on the public website.

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 the life sciences industry 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 Regulation of Clinical Trials in the United Kingdom (UK)

Now the UK has left the EU, it is no longer able to take part in the European regulatory network for clinical trials, and regulatory responsibilities have transferred to the Medicines & Healthcare Products Regulatory Agency (MHRA). The MHRA is responsible for clinical trial approvals, oversight, and inspections in the United Kingdom (UK) and alongside the UK Research Ethics Service, the MHRA grants permission for clinical trials to be conducted in the UK in accordance with the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031) as amended.  

From January 2022, all new Clinical Trials of Investigational Medicinal Products (CTIMPs) in the UK will be subject to a combined review from the MHRA and the UK Research Ethics Services, in collaboration with the Health Research Authority (HRA), facilitating rapid start up and benefitting patients sooner. Applicants need only make a single application for both Clinical Trial Authorisation and Research Ethics Committee (REC) opinion and approval is delivered together.

The MHRA is currently consulting on a set of proposals to improve and strengthen the UK clinical trials legislation to help make the UK the best place to research and develop safe and innovative medicines. The MHRA’s proposals, which are open to consultation until 14 March 2022, come after the UK government pledged in 2021 in a life sciences vision developed with regulators and industry  to “radically improve” clinical trials regulation following Brexit.

Separately, as a result of the Northern Ireland Protocol, different rules will apply in Northern Ireland than in Great Britain (which covers England, Wales, and Scotland). Broadly, Northern Ireland will continue to follow the EU regulatory regime but its national competent authority will remain the MHRA.

The Clinical Trials Regulation in Spain: Insights from Europe’s Leading Player

While the entry into force of the CTR is set to have a deep impact across all EU Member States, especially after its 3-year transition period, this new Regulation will have a special significance for Spain, which holds a leading position in the European clinical research landscape, as the first European country by number of conducted clinical trials, and second in terms of sites and recruited subjects, only behind Germany.

Among other key factors, this privileged situation has often been attributed to the existence of a robust healthcare system; a well-developed logistical and research infrastructure; increasingly involved patient organizations and the strong commitment of both authorities and the industry.

Under these circumstances, it is easy to understand why Spanish authorities have been extremely diligent in not only ensuring a fast and smooth transition into the new regime established by the CTR, but also in advancing many of the new changes that the same will entail.

In this regard, already in 2015, Spanish authorities made all necessary efforts to ensure that Spain was one of the first countries to adapt national legislation to the new CTR, anticipating many of the changes envisaged in the same, in terms of less bureaucracy, reducing the average periods for approval and effective initiation of trials, from which sponsors in Spain have greatly benefited, but also in terms of more transparency, increasing disclosure obligations and improving access by patients and the general public to trial data.

Now, with the much-awaited entry into force of the CTR, Spanish authorities expect to be able to capitalise on many of the efforts made during recent years, and to further improve the position of Spain in this field, especially in regard to multinational clinical trials, in areas such as rare diseases or other fields where more specific patient populations may be targeted, in which cases, even with Spanish capabilities, given the limited number of eligible patients, the involvement and smooth coordination with multiple EU Member States is indispensable.     

1. European Medicines Agency: Clinical Trials Regulation,EU%2C%20via%20a%20Clinical%20Trials%20Information%20System%20%28CTIS%29.

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