Change ). Parties willing to participate in the VHP process should submit their requests to a mailbox coordinated by Paul Ehrlich Institute in Germany at vhp-ctfg@vhp-ctfg.eu. 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. However, exchange with stakeholders is of importance for the CTFG, thus we plan to have a virtual meeting in 2021 if a face to face meeting will not be possible. VHP procedure The Paul-Ehrlich-Institut is an Agency of the German Federal Ministry of Health. The secretariat of the group is managed by Italy. VHP is a Voluntary Harmonization Procedure applied to multinational clinical drug trials conducted in EU Member States. be changed when submitted to the national competent authorities. Parties willing to participate in the VHP process should submit their requests to a mailbox coordinated by Paul Ehrlich Institute in Germany at vhp-ctfg@vhp-ctfg.eu . The HMA contact is Massimiliano Sarra, PhD, from the Italian Medicines Agency (AIFA). Since December 2014, a new modified Voluntary Harmonisation Procedure (VHP) Guideline version 3.2 for all clinical trials of medicinal products can be used. Unanimous decision that CTA approvable Enlargement of the Voluntary Harmonisation Procedure in the number of initial applications, substantial amendments and distribution of Sponsors (worldwide: Continuation of work sharing e.g. Both the Czech Republic and the Slovak Republic were thus admitted on 19 January of that year as Member States. Fill in your details below or click an icon to log in: You are commenting using your WordPress.com account. The main criteria and improvements of the new procedure are: The participation of Ethics Committees is possible for some participating member states. If VHP assessment reaches consensus, the scientific content of the application must not NCA approval (within 10 calendar days) 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". Amended-country-specific-protocol is minimized. CTA considered approvable in some MS, with names of MS with unresolved formal approval. Phase 3 in adolescents, which should be reflected in the protocol. PROCEDURE (VHP) after the relevant systemic exposure to the medicinal product has ended for exposure to other types of genotoxicants than aneugenic compounds, the duration for applying highly effective contraception measures for women of childbearing potential, has been extended from 1 month to 6 months (one folliculogenesis cycle). National step (formal CTA, following approval at either day 30 or day 60) A single NCA will take over the duty of a Reference NCA (Rapporteur). Interplay between legislation on in vitro diagnostics (IVDs) and clinical trials, Follow-up of CTFG’s Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials. The VHP comprises three phases: Phase 1 If you are conducting a trial in two or more member states in EU. The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. DSUR, exchange of opinions or assessment on critical topics/ national Clinical Trial Applications. 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. 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. Parties willing to participate in the VHP process should submit their requests to a mailbox coordinated by Paul Ehrlich Institute in Germany at vhp-ctfg@vhp-ctfg.eu. The covering letter of a national application must indicate VHP participation (VHP number) and the applicant’s solemn declaration stating that the application has not been modified since the VHP. ( Log Out / VHP is a Voluntary Harmonisation Procedure applied to multinational clinical drug trials conducted in EU Member States.
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