The long awaited EU Clinical Trials Regulation applies from today, 31 January 2022.

The Clinical Trials Regulation (“CTR”) entered into force in 2014, but would not come into operation until the clinical trials portal and database, known as the Clinical Trials Information System (“CTIS”), had been set up and independently audited, and then six months after notification of the successful audit was published by the Commission. The development of the CTIS proved to be a challenging task and its operation was delayed several times. On 31 July 2021, Commission Decision 2021/1240/EU was published, noting the compliance of the EU portal and the EU database with the requirements set out in the CTR. As a result, the CTR would take effect on 31 January 2022. On 25 January 2022, the European Medicines Agency (“EMA”), European Commission (“EC”) and Heads of Medicines Agencies (“HMA”) made a joint announcement (press release, live broadcast) regarding the CTR, and confirmed this date of application and discussed some of the implications for clinical trials in the EU. The Commission has also published a Q&A on the entry into application of the CTR.

The CTR largely codifies the existing guidance and sets it on a statutory setting. There are also clarification to various definitions and reporting requirements. Some of the more substantial changes include:

  • The CTIS, which will allow a coordinated and streamlined application and authorisation process for clinical trials and ethical approvals throughout the EU, and which goes live today. Using the CTIS, sponsors will be able to apply for authorisations in up to 30 EU and EEA countries with a single application.
  • Simplification of the requirements for safety reports. In this regard, on 7 January 2022, the Commission Implementing Regulation (EU) 2022/20 was adopted, which sets out the rules for cooperation between Member States when assessing safety information reported in accordance with the CTR.
  • Increased transparency provisions, both in terms of information on the trial and on the results, which can be accessed through the CTIS.

More information on the content of the CTR can be found in our previous post.

What about the Directive?

The Clinical Trials Directive is also repealed today. However, the CTR foresees a three-year transition period whereby:

  • For one year, until 31 January 2023, clinical trial sponsors can still choose whether to submit an initial clinical trial application in line with the Directive or via CTIS.
  • From 31 January 2023, submission of initial clinical trial applications via CTIS becomes mandatory, but existing trials that were approved on the basis of the Directive can continue to be governed by the Directive until 31 January 2025.

In addition to the CTR, the EMA, EC and HMA announced a new initiative this month, called Accelerating Clinical Trials in the EU (“ACT EU”). This is intended to build on the CTR and the CTIS by further strengthening the European environment for clinical trials. The ACT EU strategy paper lists ten priority actions for 2022/2023, including enabling innovative trial methods, establishing a multi-stakeholder platform, and supporting the modernisation of good clinical practice.

Application in the UK

Meanwhile in the UK, the CTR will not apply, as it did not apply in the UK at the time the UK exited the EU. It is yet to be seen to what extent the UK will align its legislation with the CTR. However, the MHRA has recently launched an 8-week public consultation on proposals to update the current UK clinical trials legislation. The proposals aim to streamline clinical trial approvals, support innovation, increase transparency, promote patient and public involvement in clinical trials, as well as ensuring international alignment and cooperation for clinical trials. The consultation closes at 11pm on 14 March 2022.