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A sponsor's experience with the Voluntary Harmonization Procedure for clinical trial applications in the European Union

Nature Reviews Drug Discovery volume 10, page 393 (2011)Cite this article

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A recent interview with Hartmut Krafft ('An audience with... Hartmut Krafft. Nature Rev Drug Discov. 9, 426 (2010))1 discussed the Voluntary Harmonization Procedure (VHP) for the assessment of multinational clinical trials in the European Union (EU). This pilot programme was established to help address the issues that arose from the implementation of the EU Clinical Trials Directive 2001/20/European Commission (EC) in 2004 into national laws and regulations, which led to divergent review processes for clinical trial applications (CTAs) in the 27 EU member states. It is apparent that a harmonized EU-wide approach for the approval of CTAs is especially important in the context of multinational clinical trials in which various National Competent Authorities (NCAs) and ethics committees are involved. However, there are still different country-specific CTA content formats, evaluation criteria, review timelines and language requirements in place.

Here, as the first commercial sponsor to contribute to the pilot VHP, we describe our experience, which shows that the VHP can be successfully utilized as a valuable strategic tool to achieve faster CTA approvals of multinational clinical trials and to speed up global drug development.

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References

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Acknowledgements

Merck Serono thank P. Delgado-Romero for her valuable scientific and editorial input during the course of the preparation of this publication.

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  1. Georgios Amexis and Elmar Schmitt are at the Global Regulatory Oncology/Regulatory Oncology EU, Merck KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Germany.,

    Georgios Amexis & Elmar Schmitt

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  1. Georgios Amexis
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  2. Elmar Schmitt
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Correspondence to Georgios Amexis.

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Amexis, G., Schmitt, E. A sponsor's experience with the Voluntary Harmonization Procedure for clinical trial applications in the European Union. Nat Rev Drug Discov 10, 393 (2011). https://doi.org/10.1038/nrd3202-c1

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