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BioIndustry Association Release: Improved Voluntary Harmonization Procedure Delivers Significant Benefits for the Conduct of Multinational Clinical Trials in Europe

5/16/2013 10:32:25 AM

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16 May 2013 -- 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.

For further information, please contact Robert Winder, Head of Communications,, 020 7630 2191; mobile 07825 942 934.

Voluntary Harmonisation Procedure

Version 3 of the VHP guidance document:

Performance metrics on VHPs (2009 -2012) can be found at:

BIA engagement on VHP

The BIA has been highly engaged over the last few years to get to this point.

• In 2006 the BIA developed and submitted to the CTFG and the European Commission a White Paper "Promoting Consistency of Implementation and Interpretation of the Clinical Trials Directive across EU Member States".

• In October 2007 the BIA participated in the European Commission-EMA Conference on the operation of the Clinical Trials Directive and perspectives for the future.

• In 2009 and 2011 the BIA responded, alongside EuropaBio, to the Commission's consultations on the revision of the Clinical Trials Directive.

• In 2009 the BIA fed back members' views and comments on the VHP process at our meeting with the CTFG.

• In 2011 the BIA submitted to the CTFG a detailed report summarising the experience gained by member companies and providing some key considerations for companies planning to use the VHP and our members' recommendations for improvement to the procedure.

• The BIA also participated in stakeholder workshops and continued regular dialogue with the CTFG's Chair and Co-Chair.

BioIndustry Association

Founded over 20 years ago at the infancy of biotechnology, the BioIndustry Association (BIA) is the trade association for innovative enterprises involved in UK bioscience. Members include emerging and more established bioscience companies; pharmaceutical companies; academic, research and philanthropic organisations; and service providers to the bioscience sector. The BIA represents the interests of its members to a broad section of stakeholders, from government and regulators to patient groups and the media. Our goal is to secure the UK's position as a global hub and as the best location for innovative research and commercialisation, enabling our world-leading research base to deliver healthcare solutions that can truly make a difference to people's lives. For further information, please go to

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