The Biotechnology Working Party (BWP) of the CPMP has reviewed a number of pegylated recombinant proteins for marketing authorisation under the European Centralised Procedure.
In its review, the BWP has identified that the basis for the statement of strength and composition in the SPC is not explicit. In order to harmonise the approach to defining the qualitative and quantitative composition of this class of products, the Committee for Proprietary Medicinal Products and its Biotechnology Working Party and Efficacy Working Party has made definitions and positions.
more information
