Eudralex Volume 3 GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING BIOTECHNOLOGY-DERIVED PROTEINS AS ACTIVE SUBSTANCE: QUALITY ISSUES

Title:
Eudralex Volume 3 GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING BIOTECHNOLOGY-DERIVED PROTEINS AS ACTIVE SUBSTANCE: QUALITY ISSUES

https://www.gmp-compliance.org/files/guidemgr/GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING.pdf

Origin/Publisher:

European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/

Document Type:
Guideline
Content:
This guideline addresses quality issues during demonstration of comparability for Similar Biological Medicinal Products containing recombinant DNA-derived proteins. As a consequence, the principles adopted and explained in this document apply to proteins and peptides, their derivatives and products of which they are components (e.g. conjugates). For other situations see Guideline on Similar Biological Medicinal Products, CHMP/437/04.

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