Claudia Garimberti -

The Voluntary Harmonisation Procedure (VHP) is a harmonised procedure for assessing multinational clinical trials (involving 2 or more member states) by the National Competent Authorities (NCA) in the EU. A single application, submitted to the Clinical Trials Facilitation Group (CTFG) is assessed in a single procedure by the Competent Authorities of those Member States where the clinical trial is to be performed.

The procedure follows fixed timelines. Once the applicant is notified that the Clinical Trial Application (CTA) is considered acceptable, the CTA must be submitted to each participating Member States as outlined in the Clinical Trial Directive and according to national regulations of the Member States no later than 20 days after receipt of the VHP acceptability statement. In Italy, the CTA must be submitted via the “Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali” (OsSC).

The National Competent Authorities should then issue their decision within 10 days.

The VHP therefore allows a quick assessment by the Competent Authorities within fixed timelines.

However, so far the VHP has not involved the Ethics Committees, whose opinions are issued only during the national phase, according to standard timelines. This causes delays in the start of the Trial as the quick CA assessment is not matched by equally rapid EC assessments, which follow the traditional timelines.

In order to overcome this limitation and bridge the gap left by the VHP, a pilot project has been started in Italy for the joined assessment of CTAs and relevant amendments by AIFA and the Ethics Committees.

To date, about 67 ECs (out of 99 total ECs) have agreed to take part to this pilot project.

According to the procedure, AIFA will keep the contacts with the VHP-coordinator, the other EU Competent Authorities and the Italian Coordinating Ethics Committee (CEC). Since only CAs have access to the VHP database, AIFA will provide documents to the CEC and will collect the CEC’s objections/comments/opinions for inclusion into the national assessment report or list of objections. The CEC will be responsible for keeping the contacts with the other involved satellite ECs.

The documents assessed during the VHP are limited to the following:

  • General information: cover letter, CTA form, list of involved NCAs
  • Protocol-related information: Protocol, protocol synopsis in English
  • IMP-related information: IMPD, IB
  • NIMP-related information
  • Additional information: Scientific Advices and PIP summary reports (if applicable)

Site-specific documents are not the object of the VHP and will not be assessed during VHP. However, it is recommended that the assessment of these documents is done in parallel. The Sponsor shall therefore send site-specific documents (e.g. ICFs, letter for GPs, CV of the PI, draft economic agreement, insurance certificate, material to be given to the subjects, etc) directly to the ECs as soon as possible in order not to delay the national approval.

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