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EMA: EMA Guideline on Quality of biological active Substances produced by transgene Expression in Animals

26.09.2013
In May 2013 the CHMP adopted the Guideline on Quality of biological active substances produced by transgene expression in animals. The date for coming into effect is the 1 December 2013. It will replace the guideline on ‘Use of transgenic animals in the manufacture of biological medicinal products for human use’ .