New EU Clinical Trial Regulation brings positive and negative changes

February 16, 2022

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By Mark Buckingham, recall advisor

The European Union Clinical Trial Regulation (CTR) recently came into force and introduced a unified regulatory regime that applies to all EU member states.

While the goal of the CTR is to reestablish the EU’s competitiveness in the field of scientific research, the CTR also creates significant obstacles for companies that aren’t established in the EU.

The positive: standardised procedures and increased transparency

A key component of the EU CTR is the standardisation of the procedures for obtaining approval for and conducting clinical trials in the EU. Under the previous EU Clinical Trials Directive (CTD), clinical trial regulations fell to individual member states, who all created slightly different procedures. The EU CTR creates a unified regulatory regime that will apply to all member states across the EU.

Toward that end, the EU CTR also provides for the creation of a single Clinical Trials Information System (CTIS), an electronic platform that will centralise all procedures for obtaining approvals to conduct clinical trials in the EU. The European Medicines Agency (EMA) has called CTIS the “backbone” of the CTR, as it will be the single entry point where clinical trial sponsors can enter trial data for assessment by the relevant authorities.

Instead of the prior process, where sponsors had to submit clinical trial applications separately to national competent authorities and ethics committees in each relevant country to gain regulatory approval, the CTR allows sponsors to submit one application online via CTIS. CTIS will also enable national regulators to collaboratively process applications in more than one country, request further information, authorise or refuse a trial and oversee an authorised trial.

Additionally, CTIS will increase transparency around clinical trials in the EU, as the platform allows any individual or interested party to access information about clinical trials conducted in the European Economic Area (EEA) through a searchable public website.

The negative: clinical trial sponsors must be established in the EU

Whilst the EU CTR will ease certain obstacles by creating a harmonised process for conducting clinical trials, it will also prevent certain groups from carrying out clinical trials in the EU. Under the CTR, legal representatives and clinical trial sponsors must be established in the EU. This new rule means that contract research organisations (CROs) based in the United Kingdom — who have previously been top choice partners for United States’ companies conducting trials in the EU — or other countries will not be able to sponsor clinical trials in the EU unless they have established a presence in the EU.

In response to the EU CTR, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on proposals for legislative changes for clinical trials. This consultation is intended to update current UK clinical trials legislation and make the UK a “go-to place to develop new and innovative healthcare products.” With both the UK and the EU enacting new legislation and regulations geared towards increasing competitiveness and innovation, companies will have to weigh the positives and negatives of where they will choose to do business.

For companies that decide to conduct clinical trials in both the EU and the UK, there will likely be many regulatory differences. Although there is a three-year transition period for the EU CTR and the UK has yet to announce new clinical trial legislation, there will be a steep learning curve for companies implementing these new regulations.

Companies doing business in the EU should begin the transition from CTD to CTR as soon as possible, while UK companies should take the opportunity to participate in the MHRA’s consultation and keep a close eye on further communications about clinical trial regulations.

Trusted by the world’s leading brands, Sedgwick has managed more than 5,000 of the most time-critical and sensitive product recalls in 60+ countries and 20+ languages, over 25 years. To find out more about our experience within the pharmaceutical industry and healthcare, visit our website.

Tags: Brand protection, clinical trial, Europe, European Union, European Union Clinical Trial Regulation, Healthcare, pharmaceuticals, regulation, Regulatory, View on brands