25 May, 2022
On 31 January 2022, the European Commission Regulation No. 536/2014 on the clinical trial of medicinal products for human use entered into force, and on this day the European portal for clinical trials, the so-called Clinical Trials Information System – CTIS, was launched. Through this portal, all clinical trial documentation will in future be submitted to regulatory authorities and ethics committees for approval. We are now in a transitional period (until 31 January 2023), when the sponsor of a clinical trial can decide whether to submit the study to the authorities in the current way under Directive 2001/20 / EC or in a new way under Regulation 536/2014. At the same time, by 31 January 2025, all ongoing studies will have to be transferred to CTIS, as from this date all clinical trials will be authorized and will take place exclusively in accordance with the new regulation (https://www.sukl.cz/leciva/dulezita-informace- pro-zadatele-o-klinicke-hodnoceni-k-1).
Research infrastructure CZECRIN participated in the preparation of the international platform study EU-SolidAct (sponsor – Oslo University Hospital), which was successfully transferred and approved through CTIS as the first international study in the whole of Europe. All 13 authorities involved gave their assent. Another sub-protocol of the EU-SolidAct study is currently being reviewed through CTIS.