Draft Document: European Pharmacopoieia on Raw Materials for the production of cell-based and gene therapy medicinal products (Pa/PH/Exp. RCG/T (14) 5 ANP) out for comments

 

The European Pharmacopoieia has published a draft chapter on raw materials for the production of cell-based medicinal products and gene therapy medicinal products, applying this to sera and serum replacements, proteins produced by recombinant DNA technology such as growth factors, cytokines, antibodies, enzymes and hormones, proteins extracted from biological material, and vectors. All comments should be submitted by the end of December to http://pharmeuropa.edqm.eu using the following template:

Template_Comments Table_en_Ph Eur draft5_2_12

In this respect, it will be interesting to see as to how vectors will be looked upon by the national authorities and EMA, with questions arising as to the classification as actiphe pharmaceutical ingredients and starting materials in some EU member states, and as starting materials in others.

Draft EP 5-2-12 Raw Materials for ATMP