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Sponsors should take action to protect commercially confidential information

In brief

The new Clinical Trials Regulation (CTR) became applicable on 31 January 2022, following achievement of the full functionality by the new Clinical Trials Information System (CTIS), bringing more transparency into the area of clinical trials.

CTIS is a publicly accessible system that contains the data submitted in accordance with the CTR. The CTIS was set up to streamline the flow of information between the EU member states, the sponsors and the EU members states and to enable access of the EU citizens to information on medicinal products. It is operated by the European Medicines Agency.

In principle, the information in the CTIS is public. However, to protect the legitimate economic interest of sponsors, the CTR provides for a carve-out to protect sponsors’ commercially confidential information. Sponsors will be able to rely on this carve-out as discussed in more detail below. Sponsors are advised to review the draft Guidance document on how to approach the protection of personal data and commercially confidential information in documents uploaded and published in the CTIS that is currently under the public consultation and submit their comments by 8 September 2022.

Read the full alert here.


Els Janssens is a Counsel in commercial law, litigation and healthcare regulatory issues in the Brussels office. Els worked as a senior regulatory legal counsel for Johnson & Johnson supporting the company's global safety operations and advising on regulatory issues in relation to specific medicinal products. Els also worked as legal advisor in the European Medicines Agency where she advised management, scientific committees, CMD(h) and the European Commission on a wide variety of issues in connection with authorisation procedures, submission requirements, pharmacovigilance obligations and procedures as well as inspections. Based in Abu Dhabi from 2014 to 2019, she advised both multinational medical devices and pharmaceutical clients on healthcare regulations in the EU and UAE.


Olha Sviatenka is an Associate in Baker McKenzie, Kyiv office.

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