A Short Summary of the Regulations for Clinical Trials Across the EU – Upcoming Changes & Considerations

March 29, 2021

The European Union is composed of 27 different countries who have agreed to keep close economic ties, as well as to create a legislative ecosystem that facilitates joint or cross-border ventures. Thanks to these efforts, there are a similar number of European clinical trials per year as the United States.

In order to ensure the region remains a competitive and attractive option for multi-country clinical trials, this regulatory framework has had to evolve with the industry. Currently, the region is transitioning between two overarching dispositions. Here, we will offer some pointers on the differences between them, as well as their implications on trial registration, ethics, information management, and patient confidentiality.

Current and Upcoming EU Legislation for Clinical Research

At the moment, the European Union is in the middle of a major regulatory transition. The existing Clinical Trials Directive is being replaced by a new Clinical Trial Regulation. This process is being done in stages, and it is expected to be completed by 2022. 

The Current Directive: Clinical Trials Directive 2001/20/EC

The Clinical Trials Directive 2001/20/EC was originally approved in 2001, and it entered into force among the different member states between 2003 and 2004. This Directive was created with the express purpose of establishing a unified standard for interventional clinical trials. In this way, it was hoped that all trials conducted across the EU would protect public health equally.

This Directive included:

  • Unified ethical guidelines, especially for paediatric trials and those involving incapacitated adults.
  • New rules for trial safety, especially for collecting and verifying any adverse events.
  • A standardised process to register any trial in the European Clinical Trials Database, or EudraCT.
  • Quality control requirements and manufacturing standard for investigational medicinal products.

The New Clinical Trials Regulation

On the 16th of June, 2014, the European Parliament approved Regulation EU No 536/2014. Eventually, this will completely replace the existing directive.

The Clinical Trials Regulation was created to improve the existing processes outlined by the Directive. It keeps a special focus on assisting the implementation of large, multi-country pharmaceutical trials. Because of this, it has a larger scope, and it introduces new processes to register new trials and to report any adverse events.

The new Regulation will rely on a unified IT portal, the Clinical Trial Information System. This will consist of a single web-based platform to submit applications to the EMA, notify relevant parties, and to communicate between national authorities, ethical committees, and sponsors.  It will also include simpler tools to allow all citizens to look up any ongoing trials.

Furthermore, the Regulation will also set the ground rules to start, suspend, hold, or terminate a trial.\(^3\) Some of these new unified rules include:

  • The concept of “one-time consent” for the use of patient’s data and samples, in keeping with the GDPR
  • A final timeline for the approval of applications by Member states
  • A new definition of “ultra rare diseases”

Implications of these changes

Currently, clinical trials need to be registered under the EudraCT system, and then seek approval in each participating country. By establishing a single-portal, single-point and “single decision” approval process, the new Regulations will:

  • Cut the administrative costs attached to trial planning
  • Provide uniform patient safety standards for all EU clinical trials\(^4\)
  • Foster greater transparency between sponsors, researchers, and the general public
  • Facilitate co-sponsored studies between the private and public sector
  • Simplify data management for multi-country trials.

Data Protection and Privacy

The new Clinical Trials Regulation is bringing about a greatest emphasis on transparency. However, the European Union also considers patient privacy to be a priority. Whenever sharing information across sites, or with regulatory agencies, European clinical trials will also need to take into account the existing General Data Protection Regulation or GDPR.

The GDPR uses a broad definition of “protected data” which includes any personally-identifiable information. It also sets extra protections for medical information, as it is considered specifically sensitive.

The GDPR was designed to implement and protect the following principles:

  1. The accountability for any possible data breaches, by assigning a “data protection officer.”
  2. The need for explicit consent before sharing any personal information.
  3. The right to revoke this consent later on, and to have your data deleted (or the “right to be forgotten”).

What Happens Next?

The Clinical Trial Information system was recently assessed by the European Commission (EC). On July 31st 2021, they granted their final approval and published it in the Official Journal of the European Union.\(^5\)

This final announcement has set the clock ticking. On January 31st 2022, exactly six months after the announcement, the CTIS will go live. This will finalize the implementation of the Clinical Trials Regulation.

Further Information

Dokumeds is a CRO with extensive experience organizing multi-country clinical trials in Europe. We specialize in helping international clients to assess, implement, and conduct both interventional and non interventional studies across countries of Dokumeds operations.

Learn more about the current process for EudraCT registration, the structure of the new CTIS and the concrete implications of regional data protection legislation in our e-book: Navigating Clinical Trial Regulations in the EU.


  1.  https://ec.europa.eu/health/human-use/clinical-trials/directive_en
  2. https://www.fieldfisher.com/en/sectors/life-sciences/life-sciences-law-blog/new-implementation-date-of-the-clinical-trial-regu
  3. https://ec.europa.eu/health/documents/eudralex/vol-10_en
  4. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2021:275:TOC

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