GDPR – General Data Protection Regulation and clinical trials
Notice to clinical trial sponsors that SÚKL shall not assess nor approve documents pertaining to personal data processing and protection
8. 12. 2017Posting of clinical trial summary results in European Clinical Trials Database (EudraCT) is mandatory
State Institute for Drug Control announces that the posting of summaries of clinical study results in the European Clinical Trials Database (EudraCT) is mandatory
28. 07. 2016Ways of submission of additional documents during Clinical Trial
State Institute for Drug Control, Clinical Trials Department informs about ways of submission of additional documents during Clinical Trial of human medicinal products.
26. 02. 2016Refund of Reimbursement of Costs for Clinical Trial Applications
Clinical Trials Dpt. of the State Institute for Drug Control informs about the procedure for refunds of reimbursement of costs for Clinical Trial Applications
4. 11. 2015Overview of documents, which are approved/acknowledged/left without any feedback by Institute on the field of Clinical Trials
Overview of possible ways of response of Institute to documents, which are submitted during Clinical Trial of human medicinal products to Clinical Trials Dpt.
27. 05. 2014Important notice for Clinical Trials Sponsors to Information for Patients/Informed Consent Form
Information of SÚKL to Approval of Information for Patient / Informed Consent Forms
19. 03. 2014Important information for Applicants for Clinical Trials
State Institute for Drug Control notifies to Applicants for Clinical Trials that will not temporarily participate in the assessment of applications under the Voluntary Harmonisation Procedure (VHP).
15. 10. 2013Information about requirement of submission of Clinical Study Reports
Current information for sponsors, contact persons, CRO, about the requirement to submit the Clinical Study Report to State Institute for Drug Control (hereinafter „Institute“).
18. 07. 2013Information for sponsors - 10.7.2008
Information for sponsors on the import of pharmaceuticals containing narcotic drugs and psychotropic substances - update.
10. 07. 2008Information for applicants
Up-to-date information for applicants (e.g. sponsors, contact persons, CRO) submitting applications for approval of a clinical trial on products of the following nature: gene therapy medicinal products, somatic cell therapy medicinal products (including cells of xenogeneic origin) or medicinal products containing genetically modified organisms.
17. 05. 2006Clinical trials on products containing genetically modified organisms
Instructions for applicants concerning requirements of the Czech Ministry of the Environment.
3. 09. 2004