Important Information for Applicants for Clinical Trials through the Voluntary Harmonisation Procedure on the Possibility of Involvement of Multicentric Ethics Committees, So Called VHP Plus (HMA CTFG website refers)

The State Institute for Drug Control hereby informs the sponsors of clinical trials  that as part of the VHP Plus project, starting from February 2018 in the Czech Republic, multicentric ethics committees may also be involved in the assessment of clinical trial applications under the Voluntary Harmonisation Procedure (VHP). The joint assessment process will be coordinated and safeguarded by coordinators of Czech competent authority the State Institute for Drug Control.  

The State Institute for Drug Control will continue to accept participation in VHPs without limitation.

For the time being, multicentric ethics committees will be involved partially, upon compliance with the conditions set forth below and with regard to the capacity of the respective multicentric ethics committee in VHPs as follows:

Conditions for acceptance of a multicentric ethics committee´s participation in VHP:

  • When submitting an application for the assessment of a clinical trial under a VHP, the sponsor should   state whether they also request involvement of a multicentric ethics committee and, concurrently, should select and identify one from the list of 11 multicentric ethics committees.
  • In VHPs, multicentric ethics committees will assess only the Protocol and the Investigator´s Brochure.

In order to safeguard transparency and facilitate orientation in the current situation, we will regularly (at least on a weekly basis) update the table of multicentric ethics committees’ capacity in VHPs. Situation as of 31st October 2018.

 

Multicentric ethics committees (MEC) capacity:

MEC, University Hospital (FN) Motol, Prague 5

 X

 

MEC, General University Hospital (VFN), Prague 2

 

 

MEC, Institute of Clinical and Experimental Medicine and Thomayer’s Hospital (IKEM & TN), Prague 4

 

MEC, University Hospital (FN) Královské Vinohrady, Prague 10

 

 

MEC, University Hospital (FN) Hradec Králové

 

 

MEC, University Hospital (FN), Jihlavská, Brno - Bohunice

 

 

MEC, St. Ann´s University Hospital (FNUSA), Brno

 

 

MEC, University Hospital (FN) Olomouc

 

 

MEC, University Hospital (FN) Ostrava - Poruba

 X

 X

MEC, Krajská nemocnice (Hospital) Liberec

 

 

MEC, Vítkovická nemocnice (Hospital) Ostrava

 

 

 

Explanatory notes

Fully occupied

 X

Free capacity

 

 

  • In a national submission of an application for clinical trial approval, the sponsor should submit the application to the same multicentric ethics committee as was involved in the VHP and which assessed the relevant documentation (Protocol and Investigator’s Brochure) in the VHP. The sponsor should submit to the multicentric ethics committee the same Protocol and the same Investigator´s Brochure (identical version) as those assessed and approved in the VHP and, concurrently, should submit a declaration that these documents are identical (a similar course of action as that of submitting an application to the State Institute for Drug Control).
  • The costs of the assessment of the application of the multicentric ethics committee will be reimbursed by the sponsor only upon the national submission of the application. If the application is rejected in the course of the VHP, the sponsor will still be charged for multicentric ethics committee assessment, an invoice for acts carried out will be issued.
  • In case the sponsor does not specify a particular multicentric ethics committee in the application for clinical trial assessment within the VHP, or the multicentric ethics committee selected thereby is already fully occupied, the application will be assessed in the VHP only by the competent authority, i.e. only by the State Institute for Drug Control.
  • The VHP Plus project covers only the primary submission and assessment of the clinical trial application, it does not cover the assessment of amendments to a previously submitted initial documentation in VHP.

The list of participating national competent authorities in the VHP Plus project is available from the HMA (Heads of Medicines Agencies) website here.

Should the situation change, we will keep you informed.

 

 

Department of Clinical Trials

08.02.2018