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Clinical Trials

10/ 09/ 2021
  Introduction of prepayment for services on the expertise of materials of CT of medicines EBA CTS requested the State Expert Center of the MOH of Ukraine (hereinafter SEC) to settle down the issue of the extension of the launch of the expertise process of the clinical trials (CT) materials to 2-3 weeks since the SEC reverted to the launch of expertise of the CT materials only after payment. Such extensions negatively affect the general deadline for approval of the CT conduct and significant amendments (SA), which in turn negatively affects the attractiveness of Ukraine for CT sponsors.  In order to settle down this issue, the EBA CTS developed a proposal and suggested the SEC to introduce the possibility of prepayment for expertise services prior to the submission of CT materials. As a result of the joint discussion of the SEC proposals, the SEC introduced a mechanism for payment in advance for services on specialized evaluation of the materials of CT/SA. This mechanism will foster the proper planning of expert work to optimize the general timing of expertise of materials of clinical trials of medicines.

Introduction of prepayment for services on the expertise of materials of CT of medicines

EBA CTS requested the State Expert Center of the MOH of Ukraine (hereinafter SEC) to settle down the issue of the extension of the launch of the expertise process of the clinical trials (CT) materials to 2-3 weeks since the SEC reverted to the launch of expertise of the CT materials only after payment. Such extensions negatively affect the general deadline for approval of the CT conduct and significant amendments (SA), which in turn negatively affects the attractiveness of Ukraine for CT sponsors. 

In order to settle down this issue, the EBA CTS developed a proposal and suggested the SEC to introduce the possibility of prepayment for expertise services prior to the submission of CT materials.

As a result of the joint discussion of the SEC proposals, the SEC introduced a mechanism for payment in advance for services on specialized evaluation of the materials of CT/SA. This mechanism will foster the proper planning of expert work to optimize the general timing of expertise of materials of clinical trials of medicines.

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