On 31 January 2023, the new Clinical Trials Information System (CTIS) established by Regulation (EU) 536/2014 on clinical trials (CTR) became mandatory. In a nutshell, pharmaceutical companies sponsoring clinical trials in the EU should be aware that:
- Clinical trial applications must now be lodged through the CTIS, the single-entry point for the submission and assessment of clinical trials under the CTR;
- The CTR imposes increased transparency obligations, as all data regarding clinical trials authorized through the CTIS must be made publicly available unless confidentiality is justified to protect commercially confidential information (CCI) or protected personal data (PPD).
The CTR became applicable in the EU on 31 January 2022, repealing Directive 2001/20/EC on clinical trials (CTD) as of the same day. However, the CTR introduced a one-year transition period (i.e., until 31 January 2023) during which sponsors could choose whether to submit new clinical trial applications under either the old regime governed by the CTD or the new CTIS. Following the transition period, the use of the CTIS became mandatory, making it no longer possible to lodge clinical trial applications under the CTD. The CTIS harmonizes the approval procedure for clinical trials in the EU, allowing sponsors to submit a single application to run a clinical trial in up to 30 EU/EEA member states at the same time. This is a radical change, as under the CTD sponsors had to seek separate approval from national authorities in each country where the trial was to be conducted
Use of the CTIS triggers the applicability of the new transparency requirements set forth in the CTR. These new transparency obligations make a decisive step towards a full-disclosure approach, expanding and widening the proactive publication of clinical trial data that the European Medicines Agency (EMA) has been endorsing over the last years based on its Policy 0070. Under the CTR, the general rule is that all information regarding clinical trials authorized through the CTIS must be made publicly available unless it qualifies as CCI or PPD, where “CCI” means any information which is not in the public domain or publicly available and which disclosure may undermine the legitimate economic interest or competitive position of its owner.
As clarified by EMA in several guidelines (some of which are still in draft version), the redaction of documents – especially with respect to CCI – should be limited and must be duly justified. Moreover, EMA introduced alternative mechanisms to avoid heavy redactions, such as the possibility to defer publication of certain data to protect CCI or the ability to upload to the CTIS redacted versions of documents “for publication” alongside versions “not for publication”.
The use of the CTIS system and the applicability of the transparency requirements established by the CTR will have a major impact on companies sponsoring clinical trials in the EU, allowing for the first time the general public – as well as competitors – to access an unprecedented volume of data regarding the development and investigation of medicinal products. In this scenario, the identification of what may qualify as CCI – and thus may be redacted and kept confidential – becomes pivotal to protect information which disclosure may undermine companies’ legitimate economic interests and competitive position.
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