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European regulators and industry to continue focus on international harmonization

The European Diagnostic Manufacturers Association (EDMA) and Eucomed, the European medical technology industry association, confirmed their commitment to continuing to collaborate on the development of robust, globally consistent regulatory systems that will facilitate access to innovative, safe, effective, and high-quality, clinically beneficial medical technologies for the benefit of patients worldwide. The announcement came after what Eucomed called "the outcomes of the constructive discussions that took place at the last Global Harmonization Task Force (GHTF) Steering Committee," which was held May 11-13 in Brisbane, Australia.

During the three-day summit, Eucomed says it became apparent that GHTF members appreciated the work of the GHTF Steering Committee over the past decades. There has also been a useful exchange of views on desirable elements of future forum.

Philippe Jacon, EDMA ad interim director general, said, “I am particularly pleased with the outcomes of the GHTF Steering Committee as the planned work was taken further, and the support for existing GHTF guidance was reaffirmed.”

The Steering Committee confirmed the review of the existing Study Group Works Plans and progressed on planned work. An overall consensus was reached on the necessity of enhancing international harmonization, which was seen as a critical part in maintaining public health.

“There is a real opportunity for regulators and industry to participate in the new direction this forum will take, and I believe that all the members of the Steering Committee can be congratulated for the work they have done over the past decades. We look forward to continuing to work with all the members of the GHTF towards harmonized regulations, which will enhance public health,” said John Wilkinson, Eucomed's chief executive.

Both EDMA and Eucomed fully support the work done by the GHTF and will remain active partners in the work of the future GHTF. Transition planning by regulators and industry is under way, the groups said.

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© 2012 Penton Media Inc.


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