In case of initial submission Hungary takes part in VHP Plus procedure involving Ethics Committee (ETT-KFEB) in the assessment of benefit/risk, IB and protocol (no other documents). During the National Phase Ethics Committee gives its opinion regarding only other (national) documents as ethical opinion about benefit/risk, IB and protocol already exists.
VHP+PILOT procedure in Hungary
Hungary plans to introduce VHP Pilot project in parallel to VHP Plus procedure from September 2018.
VHP procedure is a potential model for the clinical trial authorisation procedure before the implementation of the new Regulation 536/2014 in Europe. In most countries this procedure reduces the time period required for the authorisation of multinational studies. Nevertheless according to the Hungarian Law the authorization period for Hungary is 75 days compared to the 10 days given in the VHP Guidance document. The reason for this is that the national phase authorization procedure in Hungary includes the ethical committee’s (ETT-KFEB) evaluation as well. In order to decrease this long authorisation period and to prepare for the new CT Regulation Hungary gives possibility for the Applicants to submit national documentation (patient and site documentation) in parallel to the VHP Plus (VHP+) procedure.
This is called VHP+PILOT procedure in Hungary. As the ethical opinion already exists at the National step, the authorisation period is going to be decreased.
1. VHP+PILOT procedure:
The Applicant informs the VHP-A by sending the request for VHP Plus to VHP-CTFG@VHP-CTFG.eu via e-mail/Eudralink highlighting the involvment of the ethics committee (ETT-KFEB) in Hungary. This involves only the assessment of the submitted documents on the benefit/risk, investigators brochure and study protocol in the VHP and no other documents.
In VHP+PILOT procedure the Applicant has a possibility to send national documentation in parallel to the VHP Plus application to the OGYEI via e-mail VHP@ogyei.gov.hu. Please give VHP Number and write VHP+PILOT in the subject of the e-mail.
Timelines in VHP Plus procedure are given in VHP Guideline: http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2016_06_CTFG_VHP_guidance_for_sponsor_v4.pdf
The final opinion of the ethics committee in VHP+PILOT procedure is also sent to the applicant according to the same deadline.
2. National step:
In the national step the documentation which have already been assessed and approved by OGYEI and ETT-KFEB in VHP+PILOT procedure is to be submitted to OGYEI without any modification. The e-mails with the VHP and ETT-KFEB approval, and the statement ensuring that those versions are the ones approved in the VHP must be attached.
OGYEI forwards the documentation to ETT-KFEB and gives it’s final decision with ETT-KFEB final decision in about 15-20 days.