After approval from VHP the national submission should explicitly state in the covering letter that the information provided is the same as that has been approved by the VHP. The CTFG would like to inform stakeholders that due to the health emergency situation related to Covid-19 and the subsequent measures taken by  countries, the meeting, initially scheduled for the fourth quarter of 2020, will instead now be held in the second half of 2021. CTA considered approvable in some MS, with names of MS with unresolved If the site still contains content that does not yet reflect the withdrawal of the UK from the EU, this is unintentional and will be addressed. What is VHP and what happens during VHP processing? Once the application has passed the VHP process, a national request is submitted in Finland. If you are conducting a trial in two or more member states in EU. This proposal is not binding for the MS. the need for informing participants to seek advice about donation and cryopreservation of germ cells in line with this guidance prior treatment if applicable, has been added to the section on the need for sexual counseling of study subjects, e.g. The Heads of Medicines Agencies (HMA) agreed in 2004 to establish a clinical trials facilitation group (CTFG) to coordinate the implementation of the EU clinical trials directive 2001/20 EC across the member states. Phase 3 The aim of the meeting will be to exchange on topics of interest concerning clinical trials, including: Invitation to the CTFG Meeting with Stakeholders - 28 October 2019, Uppsala, CTFG Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials. NOTE: Phase 1 and 2 are actually composing the submission phase to the CTFG. European Union Member States national pilot projects and participation in VHP-plus in support of the transition to the new Clinical Trial Regulation EU 536/2014, May 2020 | pdf VHP procedures in preparation and in case of a no Please be informed that the Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials has been published on the HMA website under CTFG section "Key document list/Guidance". There is no fee for the VHP process, but you pay the ordinary fee to each NCA for a © Paul-Ehrlich-Institut 2020  Allows for a single initial application for the conduct of multi national clinical trials and the sponsors can obtain a harmonized assessment from all NCA in the member states participating. Its research and control activities promote the quality, efficacy and safety of biological medicinal products. ( Log Out /  In case you notice information that should be updated, please report this website link using the contact form. VHP is a Voluntary Harmonization Procedure applied to multinational clinical drug trials conducted in EU Member States. The sponsor of a CTA is required to propose one of the participating NCAs as a Ref-NCA. For Germany applicants are invited to contact the VHP administrator for details if they are interested to involve Ethics Committees in a VHP. Publication of updated Q&A documents e.g. Inclusion of Ethics Committees is only possible for initial applications. NCA review and harmonised opinion (maximum 20 calendar days), which may be: Why apply to VHP instead of national competent authorities? VHP assessment. Change ), You are commenting using your Google account. VHP procedure In the case of no Ref-NCA in spite of the Sponsor proposal and internal selection mechanisms at the end of the validation phase, a VHP will not be performed (see Guidance Document for more details). be changed when submitted to the national competent authorities. days). Please keep in mind that it is not allowed to do VHP submission in parallel with RA submissions in other EU countries which participate in VHP. The assessment is conducted and coordinated Submit CTA to all concerned NCA who consider VHP approvable (within 20 calendar Create a free website or blog at WordPress.com. adapted to meet national requirements. Phase 2 After the successful process of finding a Ref-NCAs scientific questions on the protocol and the investigational medicinal product will thus be clarified together. Parties willing to participate in the VHP process should submit their requests to a mailbox coordinated by Paul Ehrlich Institute in Germany at [email protected]. A single application submitted to the Clinical Trials Facilitation Group (CTFG) in English will be evaluated in a single procedure together by the competent authorities of those Member States where the clinical trial will be carried out. The HMA contact is Massimiliano Sarra, PhD, from the Italian Medicines Agency (AIFA). GNA forwarded to applicant Phone: +49 6103 771810 NOTE: These timelines do not apply for Member States with unresolved GNA following What is VHP? Response to GNA submitted (within 10 calendar days) Clinical trials in Europe / Voluntary Harmonisation Procedure (VHP) H. Krafft Page 6 Factors influencing multinational CT approvals between different Member states Different Application times in one Member … व षय स च - … Change ). Links to World's Regulatory Body and Gate Way to eTMF Compiled by Shah Ashraf, THE CLINICAL ENDPOINT ADJUDICATION HANDBOOK, ELECTRONIC SUBMISSION FILE FORMATS AND SPECIFICATIONS. Unanimous decision that CTA not approvable CTFG will arrange a one-day stakeholder meeting, hosted by the Swedish Medical Products Agency in Uppsala, Sweden. Request for VHP and validation of the application (5 working days). Guidance about VHP can be found in HMA´s webpage. The VHP consists of three phases VHP-Phase 1:Request for a VHP at any time Request by sponsors including the identification of the participating NCAs and submission of a full dossier-Decision by Member States to participate in A harmonised procedure for assessing multinational clinical trials in EU proposed by

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