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Ph. Eur. Commission reinstates its Gene Therapy Products (GTP) Working Party

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European Pharmacopoeia
Ph. Eur. Commission
News
17 April 2018
Strasbourg, France

Gene therapy productsThe Ph. Eur. Commission decided at its 160th session of March 2018 to reactivate its dedicated GTP Working Party and task it with the revision of general chapter “5.14 Gene transfer medicinal products for human use”. This chapter, which was last revised in 2008, now needs to take into account newly elaborated pharmacopoeial texts, such as general chapter 5.2.12 Raw materials of biological origin for the production of cell-based and gene therapy medicinal products. The Working Party will also participate in the revision of transversal texts elaborated by other Groups of Experts or Working Parties of the Ph. Eur., such as general chapter 2.6.35 Quantification and characterisation of residual host cell DNA.

While GTPs are highly innovative medicines that can act as a life-saving therapy for severe innate diseases, they are also highly complex products that present new and unique risks, as well as very specific regulatory challenges. As a way of taking into account as many aspects as possible in the fast moving sector of GTPs, the reopening of this Working Party will also be an opportunity to assess any other needs for revising general chapters or elaborating new Ph. Eur. texts related to gene therapy in consideration of the latest developments in the field of GTPs. Experts from both Ph. Eur. and non Ph. Eur. member states are welcome to participate in this work.

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