On Monday 31st January 2022, Regulation EU 536/2014 was implemented across the European Union (EU), the European Economic Area (EEA), and the United Kingdom (UK).
A significant change which will affect clinical trials is the introduction of a new electronic EU portal, the Clinical Trial Information System (CTIS).
We wanted to summarise the guidance outlined by the EMA and provide you with a snapshot of the information you should be aware.
What is CTIS and how does CTIS relate to Regulation EU 536/2014?
CTIS is the single-entry point for clinical trials information in the EU and in the EEA and went live with the implementation of the regulation on Monday 31st January 2022.
This system is being introduced to harmonise and simplify the Clinical Trials Application (CTA) process by making applications easier. Its intent is to also enhance patient safety by making information relating to clinical trials more transparent and accessible.
All member countries will now submit CTAs and input associated clinical trial information via the CTIS. The EMA will make information stored in CTIS publicly available subject to defined transparency rules.
How will Regulation EU 536/2014 and CTIS impact my organisation? Will they benefit me?
Regulation EU 536/2014 and the CTIS are intended to bring many benefits.
They will allow organisations to submit a CTA in up to 30 EEA countries with a single application applicable to all states in which the clinical trial will be conducted. So, for example, if you want to conduct a clinical trial within 6 member countries you can do so with a single CTA. This is a large part of the move to streamline the clinical trial process.
It will also facilitate more efficient information sharing and improve the coordination of safety reporting. In doing so, it is hoped that the Regulation and CTIS will contribute to a greater understanding of the benefits and potential risks of medicinal products and whether those products are already available to the public or are planned for the market. This improved information sharing and transparency should reduce the need to duplicate work and clinical trial research.
Overall, these measures should help to accelerate the CTA process whilst at the same time introduce improvements in the safety and ethical validity of clinical trials in the EU and in the reliability of data obtained from those clinical trials.
What is the transition period to CTIS?
Whilst CTIS went live on the 31st January, there is a 3-year transition period which means that sponsors do not have to use it immediately.
The EMA state:
“The Clinical Trial Regulation foresees a 3-year transition period to CTIS. Member States will have to work in CTIS immediately from go-live, once applications are submitted. Sponsors will have one year to begin using CTIS and can decide whether to submit a new clinical trial application under the Clinical Trial Directive 2001/20/EC or Regulation (EU) No 536/2014 until 31 January 2023.
All new applications for clinical trials must be submitted through CTIS as of 31 January 2023, while all clinical trials must be transferred to CTIS by 31 January 2025, if still ongoing.”
It is worth noting…
CTIS is not a clinical trial management system and therefore, should not be relied upon by sponsors to retain information generated or collected throughout the duration of the conduct of a clinical trial.
We will keep you up to date as more information becomes available. If you’d like to subscribe to our newsletter, please fill in the form at the bottom of this page.
You may find some of our other resources useful:
Webinar Recording: The meaning and impact of Regulation (EU) 536/2014
Our top 15 EU Regulation 536/2014 questions – Part 1
Our top 15 EU Regulation 536/2014 questions – Part 2
02 Nov, 2021
A Guide to EU GCP Data Management Regulations
Neuraly Case Study: Helping a revolutionary clinical-stage biotechnology company become GCP compliant
18 Feb, 2021