Related information

Posting 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  

 

Ways 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  

 

Refund 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  

 

Posting of clinical trial summary results in European Clinical Trials Database (EudraCT) to become mandatory

State Institute for Drug Control announces that the posting of summaries of clinical study results in the European Clinical Trials Database (EudraCT) becomes mandatory as of 21 July 2014  

 

Overview 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.   

 

Important notice for Clinical Trials Sponsors to Information for Patients/Informed Consent Form

Information of SÚKL to Approval of Information for Patient / Informed Consent Forms  

 

Important 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).  

 

Information 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“).  

 

Information for sponsors - 10.7.2008

Information for sponsors on the import of pharmaceuticals containing narcotic drugs and psychotropic substances - update.  

 

Information 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.  

 

Clinical trials on products containing genetically modified organisms

Instructions for applicants concerning requirements of the Czech Ministry of the Environment.