Press Release: European Medicines Agency finalises set of guidelines on similar biological medicines and publishes two more new concept papers

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Series Details EMEA/84561/2006 (8.3.06)
Publication Date 08/03/2006
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The European Medicines Agency (EMEA), on 8 March 2006, published a set of five final guidelines on similar biological medicinal products. They are intended to give guidance to industry in the development of this new type of applications for marketing authorisation.

Source Link http://www.emea.europa.eu/pdfs/general/direct/pr/8456106en.pdf
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