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Now that it has gone live, is the new Clinical Trials Regulation revolutionary?

The old Clinical trials directive 2001/20/EC was seen as bureaucratic and had many obstacles, such as not having a streamlined mechanism for authorising sponsorship of multi-centre studies to be carried out across the union. There were also fundamental flaws in the wording of the directive and clear gaps, such as a lack of a unified definition of what is an investigational medicinal product (IMP). Also, the Clinical Trials Directive didn’t have the same European-wide legal standing that a legally binding regulation would have. For a directive, each of the individual member states must implement it through local legislation for that directive to become law. This means that each member state often takes slightly different approaches, and as a result, there is resulting disharmony in how the directive is applied in each country.

Clinical Trials Regulation

This directive had been repealed and replaced with the Clinical Trials Regulation (EU) No 536/2014; (the CTR) as of the 31st January 2022. However, the Clinical Trials Directive still applies to existing trials until the 31st of January 2025.  The CTD regime may continue to be selected for new trials for an additional year until the end of January 2023, when the sponsor opts for this.

The new regulation – Clinical Trials Regulation (EU) No 536/2014, allows for much greater harmonisation as it has introduced an approval procedure which is completed via a single submission and assessment.  Terefore as a result multi-country studies can now be approved as a single decision.  However by far the biggest revolution introduced due to the Clinical trials regulation is the new submission and approvals database, the Clinical Trial Information System (CTIS).  This new database is a one-stop central hub for submitting and assessing data and trial information relating to sponsors.  CTIS allows for close review and approval of steps by the health authorities in concerned member states and also streamlines the access to data by the public.


CTR also benefits the sponsor by introducing the concept of low intervention clinical trials, which allow sponsors to define studies that present a much lower risk to patients.  As a result, the commission has taken a risk-based approach not seen in the clinical trials directive.  With low intervention studies, IMPs already have the required Marketing Authorisation, and as such, there has already been a full assessment of the safety and efficacy of the product.  For low intervention trials, sponsors can submit simplified dossiers (SmPC rather than IMPD).

There are now also much snappier timelines in the new regulation. Sponsors must respond to queries regarding their applications or RFI’s within 12 calendar days, and the applications will automatically lapse if the timelines are not adhered to.  However, it’s not all one way as there are timelines that the health authority must adhere to as well, meaning that there is clarity also for the sponsor on when a response can be expected.

The new Clinical Trials Regulation is resulting in a much more streamlined submission and assessment process through the use of a single dossier and submission for all member states at once using the CTIS database, which negates the need to work out how to submit authorisations in 27 different member states each with their own rules.

All that being said, there are certainly tighter reporting requirements and shorter deadlines. However, this isn’t always a bad thing for the sponsor who wants to get their drug to market as fast as possible.

Feedback from industry is beginning to suggest that the new regulation and the associated CTIS system for harmonised assessment will revolutionise the EU’s competitiveness in the area of drug development.  This is mainly felt in the reduced time and cost it takes to obtain clinical trials’ approval.  

Orion GXP Consulting has QP’s and subject matter experts embedded with our CRO and clinical sponsor clients and is currently working closely on training and QMS revisions to assist their transition to the revised requirements of the Clinical Trials Regulation (EU) No 536/2014.  If your company are gearing up for the next clinical trial being authorised through the new regulation or if you just need assistance in aligning your QMS to the new CTIS system and you need revisions to the QMS or help with implementation, we can assist.

Orion Consulting

To discuss your needs further contact us at or call +353 7198 10101.