New public clinical trials database leads to increased tax and regulatory transparency

Risk of supply chain disruption/recalls

Sandra Ragaz-Fumia
Leader Pharma & Life Science Consulting for Regulatory & Indirect tax, PwC Switzerland

Dominik Hofstetter
Pharma & Life Science Regulatory, PwC Switzerland

The European Medicine Agency (EMA) published a press release on 31 January 2023 related to clinical trials in the EU, announcing that the use of the Clinical Trials Information System (CTIS) will become mandatory for all new clinical trial applications in the EU.

Below is a summary of the publication, its implications and the impacts on indirect tax and pharma regulatory licensing.

Management summary

As of 31 January 2023, all EU clinical trial applications must be submitted via the clinical trials database CTIS – the single-entry point for submitting and assessing clinical trial data.
Previously, sponsors had to submit applications separately to national competent authorities (NCAs) and ethics committees in each country. CTIS streamlines the process, allowing sponsors to apply for authorisations in up to 30 countries at once. The Clinical Trial Regulation (‘CTR’) foresees a transition period from 2022 to 2025, during which all ongoing trials approved under the Clinical Trials Directive will be transitioned to CTIS.
The CTIS database is publicly available and leads to increased transparency for indirect tax and pharma regulatory licensing.
Non-compliance with EU/EEA regulations can lead to potential supply chain disruption as well as the recall of materials used in clinical trials.

Additional information

The European Union (EU) will require all initial clinical trial applications to be submitted via the Clinical Trials Information System (CTIS) as of 31 January 2023.
The CTIS will serve as the single-entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data related to investigational medical products (‘IMP’), the location of the hospitals/clinics, manufacturing/packaging site, and legal ownership etc. This move follows a one-year transition period, during which sponsors could choose to apply for a new clinical trial in the EU/EEA under the Clinical Trials Directive or the new Clinical Trials Regulation (CTR), which came into effect on 31 January 2022 and ended at the beginning of this calendar year.
Previously, sponsors had to submit clinical trial applications separately to NCAs and ethics committees in each country to gain regulatory approval to run a clinical trial. Registration and posting of results were also separate processes. With CTIS, sponsors can now apply for authorisations in up to 30 EU/EEA countries simultaneously and with the same documentation. The system includes a public, searchable database for healthcare professionals, patients and other interested parties.
The CTR foresees a three-year transition period, from 2022 to 2025. The first milestone has been reached, and in two years’ time, by 31 January 2025, all ongoing trials that were approved under the Clinical Trials Directive will be governed by the new regulation and must be transitioned to CTIS.
The application of the CTR strengthens Europe as an attractive location for clinical research. The new regulation streamlines the processes for the application and supervision of clinical trials and their public registration. All clinical trial sponsors will now use the same system and follow the same procedures to apply for the authorisation of a clinical trial, no matter where they’re located and which NCA or national ethics committee they’re dealing with.
The authorisation and oversight of clinical trials are the responsibility of EU/EEA Member States, while the European Medicines Agency (EMA) is responsible for maintaining CTIS. The European Commission (EC) is overseeing the implementation of the Clinical Trials Regulation.

What does it mean for you?

CTIS is a publicly available database to which the indirect tax authorities in the EU also have access. Since this database include IMP-specific pharma information as well as information about the clinical trial supply chain, this will lead to increased transparency of the clinical trials conducted in the EU/EEA.
Since clinical trials in the EU/EEA involve different VAT registration and reporting obligations as well as regulatory licensing requirements, we highly recommend that you review the respective supply chain from:
- an indirect tax point of view and
- a pharma regulatory point of view.
Based on the increased transparency, compliance in that regard has become crucial in order to mitigate the risk of supply chain disruption and a recall of the IMP.