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Regulatory Focus™ > News Articles > A New Regulation—Advanced Therapy Medicinal Products

A New Regulation—Advanced Therapy Medicinal Products

Posted 01 December 2008

Regulation EC No 1394/2007 for Advanced Therapy Medicinal Products (ATMP Regulation)1 was published in the Official Journal on 10 November 2007 and will apply from December 2008. The regulation was anxiously anticipated by industry, since the objective was to achieve harmonized legislation, especially for tissue engineering products (TEPs), in the EU.

 

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