Regulation (EU) No. 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC (hereinafter: “Regulation”) was adopted on 16 April 2014 but its mandatory application will only be introduced as on 31 January 2022.
As stated in the Preamble of the Regulation, scientific development suggests that future clinical trials will target more specific patient populations. To include enough patients in clinical trials it has become necessary to involve many (or all) Member States. Accordingly, uniform procedures were introduced for the authorization of clinical trials to encourage inclusion of as many Member States as possible.
The main goal of the Regulation was to simplify the procedures for the submission of documentation required for the authorization of clinical trials by creating a single portal on the European Union (EU) level.
I. Clinical Trial Information System
The new Regulation brings changes in several areas, but one of its greatest achievements is the database created under the Regulation. Article 81 of the Regulation governs the Clinical Trial Information System (hereinafter “CTIS”). CTIS’s main purpose is to eliminate the submission of clinical trial applications to the national authorities of the Member States and ensure easy access to data and create transparency.
Another new feature of CTIS is that it identifies each clinical trial with a unique EU trial number. The sponsor must refer to this EU trial number in any subsequent submission related to or referring to that clinical trial.
According to Article 81(2) of the Regulation, the purpose of the EU database is to enable cooperation between the competent national authorities of the Member States for the efficient application of the Regulation and to make individual clinical trials searchable. The database will also facilitate communication between sponsors and the Member States concerned and will allow sponsors to refer to a previous application for the authorization of a clinical trial or their substantial modification.
Another advantage of the CTIS database is that it allows EU citizens to access clinical trial information on medicines.
II. Changes to the Authorization Procedure of Clinical Trials
The most significant difference between the authorization procedure of clinical trials introduced by the Regulation and the previous regulation is that clinical trial applications will not be submitted to the national authorities after 31 January 2022.
As of 31 January 2022, applicants will be required to submit their applications through the EU CTIS portal and will have to indicate on the application in which EU countries the sponsor intends to conduct the clinical trial.
The evaluation process has also been significantly changed and the process works based on a division of tasks between the Member States. The reporting Member State designated by the sponsor from among the participating Member States will be the lead Member State in the reporting process and will first evaluate the part of the application concerning all concerned Member States. The final version of the evaluation report will be the result of discussions with the participating Member States and the sponsor.
The evaluation process should be completed within 60 days. At the conclusion the concerned Member States will notify the sponsor via the EU portal whether the clinical trial has been:
- authorized subject to certain conditions; or,
- the authorization is rejected.