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null Piloting of the EU Regulation on Clinical Trials has commenced in Finland

Piloting of the EU Regulation on Clinical Trials has commenced in Finland

4.12.2020

Fimea and the National Committee on Medical Research Ethics (TUKIJA) started on 30th of November the piloting of the new clinical trials assessment process in accordance with the EU Regulation. The purpose of the piloting is to prepare for the implementation of the Regulation and the new assessment process.

According to the current estimate, the application of the EU Regulation on Clinical Trials (536/2014) will begin at the end of 2021 when the Clinical Trials Information System (CTIS) and database maintained by the European Medicines Agency are ready for deployment.

New clinical trials are needed for the pilot

The EU Regulation and the new Act on Clinical Trials on Medicinal Products will change the regulatory processing of clinical trials and intensify cooperation between the authorities. By participating in the pilot, the sponsors of clinical trials will also have the opportunity to prepare for the application of the new Regulation.

The clinical trial applications submitted via the pilot project will be assessed in accordance with the legislation currently in force, but the assessment procedure and processing times pursuant to the EU Regulation will be taken into account in the pilot where applicable.

Further information about the national pilot and participation in the pilot 

Inquiries:

TUKIJA: info(at)tukija.fi

FIMEA: clinicaltrials(at)fimea.fi