Please find hereinafter the latest news related to Clinical Trials in the EU with a respective indirect tax and pharma regulatory licensing impact:
1. Management Summary:
• Starting 31 January 2023, all EU clinical trial applications must be submitted via the clinical trial data base CTIS, the single-entry point for submitting and assessing clinical trial data.
• Previously, sponsors had to submit applications separately to national competent authorities and ethics committees in each country. CTIS streamlines the process, allowing sponsors to apply for authorizations 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 & pharma regulatory licensing.
• Non compliance with EU/EEA regulations lead to a potential supply chain disruption as well asl re-call of clinical trials material.
Continue reading New public Clinical Trials database leads to increased tax & regulatory transparency – risk of supply chain disruption / recall