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Friday 24 May 2019
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Voluntary Harmonisation Procedure

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Getting new innovative medicines to patients more quickly has become a step change easier thanks to the improved and refined Voluntary Harmonisation Procedure (VHP) for multinational clinical trials applications that the BIA has long campaigned for.
Steve Bates, BIA Chief Executive Officer, said:
"This voluntary system agreed by national regulatory authorities makes running multinational clinical trials across the EU simpler and cheaper. The BIA has advocated for these changes for a number of years and is delighted that they are making a practical difference to companies.

"I want to make sure all companies are aware of this procedure and use it - especially if the proposed EU Regulation on clinical trials is delayed for any reason." 
The VHP, a voluntary procedure agreed by the Clinical Trials Facilitation Group (CTFG), a working group of the EU Heads of Medicines Agencies, provides a major breakthrough in getting a harmonised regulatory decision on a clinical trial to be performed in more than one EU Member State.
The new version of the VHP guidance (Version 3) represents an important evolution of the VHP process, which was introduced initially as a pilot in 2009 and revised in March 2010. Among the key aspects introduced are:
  • A Reference National Competent Authority responsible for the scientific assessment, consolidation of questions and grounds for non-acceptance, and the reassessment of the sponsor's response in collaboration with the National Competent Authorities (NCAs) concerned by the trial and participating in the VHP.
  • 'Second-wave VHP' of clinical trial applications allowing sponsors to include additional Members States following a positive VHP and taking account of the original assessment.
The work-sharing aspects of the new improved VHP assessment procedure (Version 3) look very similar to how the clinical trial authorisation procedure is shaping up in the proposed EU Regulation on clinical trials following amendments suggested by the EU Council Working Party.
Alan Morrison, Vice President, International Regulatory Affairs and Safety, Amgen, and Chairman of BIA's Regulatory Affairs Advisory Committee, said:
"The BIA's Regulatory Affairs Advisory Committee has campaigned to improve the regulatory framework for clinical trials in the EU since 2006. Greater harmonisation of clinical trial authorisation review processes and cooperation among Member States are important to provide consistency to trial approval to the ultimate benefit of both patients and the life sciences sector. Every company should be using the VHP for multinational trials; only by building this experience can we be prepared to work effectively within the new regulatory framework when the EU clinical trials Regulation comes into force.

"We pay tribute to the dedication of Dr Hartmut Krafft, the Chair of the CTFG and VHP-Coordinator, and the leading role of the Paul-Ehrlich Institute in getting the VHP this far."
Dr Chris Parkinson, Director, Global Regulatory Affairs, GlaxoSmithKline, said:
"One of the significant advantages I have found with the VHP is the precise and predictable timetable for the submission, assessment, response and decision that makes for efficient and predictable planning and greatly reduces complexity for multinational clinical trials."
The BIA now plans to hold a workshop so that biotech companies can get the best out of the new VHP process.

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