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Abstract: . . . only provided the EMEA is acknowledged London, 22 February 2006 Doc. Ref. EMEA/CHMP/BMWP/9437/2006/corr COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) CONCEPT PAPER ON GUIDELINE ON COMPARABILITY OF BIOTECHNOLOGY - DERIVED MEDICINAL PRODUCTS AFTER A CHANGE IN THE MANUFACTURING PROCESS NON-CLINICAL AND CLINICAL ISSUES . . . . . . provided the EMEA is acknowledged London, 22 February 2006 Doc. Ref. EMEA/CHMP/BMWP/9437/2006/corr COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) CONCEPT PAPER ON GUIDELINE ON COMPARABILITY OF BIOTECHNOLOGY - DERIVED MEDICINAL PRODUCTS AFTER A CHANGE IN THE MANUFACTURING PROCESS NON-CLINICAL AND CLINICAL ISSUES AGREED . . . . . . approval by CHMP December 2004) Guideline on comparability of medicinal products containing biotechnology -derived proteins as active substance (CPMP/3097/02) Guideline on similar biological medicinal products containing biotechnology -derived proteins as active substance: non-clinical and clinical issues (EMEA/CHMP/42832/05) . . . . . . Guidance on Biotechnological/Biological Products Subject to changes in their Manufacturing Process (CPMP/ICH/5721/03 final approval by CHMP December 2004) Guideline on comparability of medicinal products containing biotechnology -derived proteins as active substance (CPMP/3097/02) Guideline on similar biological medicinal products containing . . . --1535,4,192,1840,7676
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