December 2021: Czech Republic Update

Decree No 463/2021 on “Detailed Conditions Governing the Conduct of Clinical Trials on Medicinal Products” has been published in the Collection of Regulations of the Czech Republic by the Ministry of Health, Czech Republic on December 10, 2021.

Decree No 463/2021 shall be applicable only to clinical trials conducted in Czech Republic and submitted via the Clinical Trials Information System (CTIS) portal and assessed pursuant to  EU Regulation No 536/2014. Decree No 463/2021 will come into effect on January 31, 2022.

More information can be found here.