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How the Clinical Trials Will Change With the Regulation (EU) No 536/2014

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Published - 06.Apr.2022

The Regulation (EU) No 536/2014 of the European Parliament, and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, will be applied effectively as of January 31st, 2022 because of the need for the development of a fully functional EU clinical trials portal and database.

The Regulation aims to ensure a greater harmonisation of the rules for conducting clinical trials throughout the EU. It introduces an authorisation procedure based on a single submission via a single EU portal, an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, and transparency requirements.

Another crucial benefit from implementing the Regulation is that it would be easier for the pharma industry to conduct multinational clinical trials, which should increase the number of studies conducted within the EU.

From Directive 2001/20/EC to Regulation (EU) No 536/2014

Until the Regulation became applicable, Directive 2001/20/EC is active for the clinical trials. The main difference between the two documents is that the Regulation will be directly applicable in all EU/EEA Member States, not relative to the Directive. The Regulation ensures that the rules for proceeding clinical trials are the same for EU/EEA and will allow assessment of clinical trial application between the Member States. 

The Directive will be repealed on the day of entry into the application of the Clinical Trials Regulation. It will, however still apply three years from that day to:

  • Clinical trials applications submitted before the entry into application
  • Clinical trials applications submitted within one year after the entry into application, if the sponsor opted for the old system

The Regulation will be applicable for the EU countries and Iceland, Liechtenstein and Norway. By now, Spain is one of the countries that has aligned its national law with the future Regulation. According to the Regulation, there are areas that the national laws should complete, such as language requirements, fees, need for EU legal representation, etc. There are also some aspects of clinical trials regulated by other local laws, such as biological samples, data protection, GMO, and radiological procedures. These aspects should be under solid control depending on countries’ specificities.

The main aim of the Regulation is to make the EU/EEA more attractive for conducting clinical trials and to provide researchers and the public with more information about clinical trials.

Тhe Regulation’s Transparency  

Due to clinical trials data, the Clinical Trials Regulation provides more transparency. All information in the EU database will be publically accessible unless its confidentiality can be justified based on protection of commercially confidential information, protection of personal data, security of confidential communication between EU countries and ensuring adequate supervision of the conduct of clinical trials by EU countries.

All requirements of the regulation will apply from the time CTIS goes live. Therefore, among other things, sponsors should carefully anticipate transparency of submissions (as stated in Article 81(4) of the Regulations). Applications for which the Member States have decided (regardless of their nature) will be made public, by default always at the first time.

The only data that will not be made public is personal data and commercially confidential information. This will mean uploading not a full version for evaluation and an edited version for publication when submitting an application.

Sponsors may choose to delay publication of specific data/documents, and the Member States will have the opportunity to evaluate sponsors’ proposals to delay publication (if applicable).

The deferral rules and the maximum time to defer the publication of data and documents will depend on the trial categories defined in the appendix, the disclosure rules, the “Functional specification of EU portals and EU databases to be reviewed – EMA/42176/2014”. 

This should be carefully considered when handing over dossiers, and sponsors will need to implement specific procedures to edit the necessary documentation and internal policies for extension requests.


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