Legal regulations govering clinical trials

Applications for clinical trial authorisation shall be submitted for both Part I and Part II dossiers via the CTIS (EU portal).

(clinical trials under Regulation 536/2014)

Nařízení 536/2014, o klinických hodnoceních humánních léčivých přípravků a o zrušení směrnice 2001/2Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

Act No. 378/2007 Coll., on Pharmaceuticals, as amended by Act 66/2017

Decree No 463/2021 on Detailed Conditions Governing the Conduct of Clinical Trials on Medicinal Products

ICH E6 (R2) – Good Clinical Practice

Guidelines of SÚKL
UST-29 – Administrative fees, reimbursements of costs of expert activities, reimbursements of activities associated with the provision of information and reimbursements of other activities– Code K-012 až K-030
KLH-22 Requirements Governing the Text of Patient Information Leaflet Trial Subject Information Sheet/Informed Consent Form

December 22, 2021

Department of Clinical Trials on Pharmaceuticals