EU-US authorities to harmonize medicines approval process

Brussels, 28 November 2007:  Today, industry will present 28 areas for simplification in the approval and marketing authorization of medicines to EU and US authorities at the Transatlantic Administrative Simplification Workshop in Brussels. The EU Commission will host one hundred participants, including the EMEA, the FDA, representatives of national competent authorities and EU and US industry representatives for this discussion, which is part of the framework of transatlantic dialogues. The workshop is expected to take the first significant steps towards reducing unnecessary administration and ultimately will reduce costs to the end-consumer and industry. One of the first steps will be a single application form for the designation of Orphan Medicinal Product at the EMEA and FDA.

The authorities will agree a priority list of topics for administrative simplification. Work to minimize duplicative or divergent administrative requirements will begin in early 2008. The results of these discussions will be published by the EU Commission and FDA in June 2008.

“The biotech industry congratulates the EU Commission, EMEA and FDA for the cooperative spirit and vision that will help to facilitate patient access to innovative treatments on a global scale and streamline the medicines approval process on both sides of the Atlantic. We hope that the meeting proactively addresses the harmonization of requirements. We will continue to support their crucial work,” said the Chair of EuropaBio’s Healthcare Council, Dr. Andrea Rappagliosi. He continued, “Transatlantic harmonization can only help in the effort to bring medical treatments to patients sooner, and is contributing to the realization of sustainable patient-centered healthcare systems.”

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For further information, contact:

Stefanie Pingitzer
EuropaBio Healtcare Council Manager
Tel: +32 2 739 1178 Mobile: +32 476 46 66 88
Email: s.pingitzer@europabio.org 

Adeline Farrelly
EuropaBio's Communications Director
Tel: +32 2 739 1174 Mobile: +32 475 93 17 24
Email: a.farrelly@europabio.org

About the TransAtlantic Business Dialogue (TABD)
http://www.tabd.com/

About EuropaBio
EuropaBio, the sole and unique European Association for Bioindustries, has 85 direct members operating Worldwide, 12 associate members and 5 bioregions as well as 25 national biotechnology associations representing some 1800 small and medium sized enterprises involved in research and development, testing, manufacturing and distribution of biotechnology products. http://www.europabio.org