EMA on Gene Therapy

The European Medicines Agency invites feedback on their latest draft guidance

In Europe, gene therapies are regulated as advanced therapy medicinal products (ATMPs) under Regulation (EC) No. 1394/2007, and are further defined in Part IV of Annex I to Directive 2001/83/EC. Thus far, EMA has only authorized a single gene therapy, Glybera, which treats a rare condition called lipoprotein lipase deficiency (LPLD).

The EMA aims to support and facilitate the development of these innovative medicines by giving guidance to developers on the types of evidence they should generate to support a marketing-authorization application with a regulatory authority in the European Union.

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