Drug database
Legal regulations govering clinical trials
1. Clinical trials submitted and approved/authorised before 1 February 2022 and clinical trials submitted nationally and approved/authorised from 1 February 2022 to 31 January 2023 (clinical trials under Directive 20/2001)
Requests for authorisation or approval of a clinical trial are submitted to the SUKL and the ethics committees (Ethic Committees for Multicentric Clinical Trials and Ethic Committee established at healthcare facilities).
| Act No. 378/2007 Coll., on Pharmaceuticals, as amended |
| Decree No 226/2008 Coll., on good clinical practice and detailed conditions of clinical trials on medicinal products, as amended |
| Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use |
| 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-001 až K-004 KLH-19 Requirements on authorisation of clinical trials on medicinal products – data required for the pharmaceutical part of the documentation KLH-21 Reporting Adverse Reactions to Medicinal Products for Human Use in a Clinical Trial and to Medicinal Products without Marketing Authorisation KLH-22 Requirements Governing the Text of Patient Information Leaflet Trial Subject Information Sheet/Informed Consent Form |
2. Clinical trials submitted via CTIS (EU portal) from 1.2.2022
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