The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
Eudralex Volume 3 GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS
Origin/Publisher:
European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/
Document Type:
Guideline
Content:
The applicants of similar biological medicinal products, who have applied for scientific advice from
the CHMP, expressed the need for specific guidance.
The advances as well as the limitations of methods and techniques available today for the full
characterization of such medicinal products have already prompted the CHMP to initiate a number of
specific guidelines relevant to quality, non-clinical and clinical issues, to be addressed within the
development programs of similar biological medicinal products.
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