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EU Clinical Trial Regulation – Defining The Change


September 28, 2021

Clinical Trial Regulation is changing for clinical trials in EU member countries. The amendment will harmonize and improve the transparency of clinical trials across the EU.

What is clinical trial regulation?

The Clinical Trial Regulation (Regulation (EU) No 536/2014) aims to standardize the assessment and supervision processes, improve co-ordination and increase transparency for clinical trials throughout the EU, by introducing a common Portal/Application called Clinical Trials Information System (CTIS). The European Medicines Agency (EMA) has set up and maintains CTIS, in collaboration with the Member States and the European Commission. It will contain the centralized EU portal and database for clinical trials foreseen by the Regulation.

Changes to the Clinical Trial Regulation have provided for a 3-year transition period, giving companies time to migrate.

  • By 31st January 2022, the regulation will come into initial effect with CTIS go-live. Sponsors will have 1 year to begin using CTIS and member states will have to work as per CTR from go live, once applications are submitted.
  • By 31st January 2023, all new applications for clinical trials must be submitted via CTIS and follow Clinical Trial Regulation.
  • And by 31st January 2025, any on-going clinical trials must have transferred across to Clinical Trial Regulation and have been entered into CTIS.

So why has Clinical Trial Regulation changed in the EU? The combination of disparate systems, unpredictable timelines and governance and control have driven a need for a redefined regulatory framework to harmonize clinical trials carried out in EU member states.

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

And what is CTIS? CTIS will become the single point of entry for submission, storage and authorization of clinical trial applications, supporting the day-to-day business processes for users. Subject to transparency rules, it will make information publicly available and interact with 5 databases, allowing users to search through information on organizations and medicinal products. It also includes a website, open to the general public & industry experts, supporting open access and driving trust on clinical trials within member states.

How will it impact my organization?

Organizations will need to re-think clinical and regulatory operations. While the most visible change introduced by the CTR amendment may be the CTIS interaction and data impact, the amendment cuts across clinical value chain nudging organizations to look at the impact holistically.

Broadly, it is expected to impact the people, process, technology and data of an organization, creating the need to:

  • Rethink roles and responsibilities as well as restructuring training programs under your operating model
  • Update process and instructions for the application process and develop stronger communication between clinical and regulatory businesses within your workflow
  • Increase First Time Quality importance, revisit ad-hoc assessment and the need to reduce TAT to facilitate agile EMA interaction through operations
  • Establish robust and accessible data storage with streamlined data flow to promote frequent submission of data
  • Enable integrations for HA interaction and custom API’s for data migration into CTIS

It’s important for organizations to prepare for Clinical Trial Regulation with a phased approach that is specific to their needs. A cookie-cutter approach will not be effective.

Every organization is unique and the impact of CTR will thereby be unique to you; your business and operating models will drive the transition plan, complexity and timelines. A thorough impact analysis across your organization will be required to plot a change journey tailored to your needs.

If you would like to find out more about how our modular solution can empower your transition to the new regulation, we would be delighted to discuss it with you further.


Vikram Aditya

Manager – Life Sciences, R&D