European News In Brief
This article was originally published in The Gray Sheet
Executive Summary
EU human tissue regulation: DG Enterprise will likely release an independent human tissue product draft directive in June 2003, arousing European industry concern over the possibility of two separate circulating directives. Eucomed's public policy focus group has responded favorably to DG Sanco's proposed directive setting out quality requirements for processing human tissues and cells, set for approval before 2004. Enterprise's initiative also was well received by industry, since manufacturers are expected to be "treated on the same basis as tissue banks." The Sanco directive, founded on Article 152 under the Amsterdam Treaty, is an EU Health Policy initiative. The DG Enterprise proposal, meanwhile, aims to create an EU-wide regulatory framework for marketing tissue products...
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Separate Tissue Product/Transplant Laws Requested To Reduce EU Reg Onus
Investment in European tissue-engineered medical devices will suffer if the European Parliament's report on a proposed directive for human tissue quality and safety standards is not amended, EU stakeholders say
Separate Tissue Product/Transplant Laws Requested To Reduce EU Reg Onus
Investment in European tissue-engineered medical devices will suffer if the European Parliament's report on a proposed directive for human tissue quality and safety standards is not amended, EU stakeholders say
International News In Brief
Siemens AG/Draegerwerk: European Commission opts to extend investigation of German hospital equipment joint venture Jan. 22. Under the deal, Siemens will transfer its ventilator, anesthesia delivery and patient monitoring businesses to Draegerwerk in exchange for a 35% share of wholly owned subsidiary Draeger Medical, which would then be jointly controlled by the two partners. The proposed transaction would lead to a combined ventilator market share that proved sufficient to trigger an in-depth inquiry by the EC, which has four months to issue a final decision on the merger...