Similar Biological Medicinal Products Containing Recombinant Human Growth Hormone: European Regulation-Reference-Cited by-同舟云学术

Similar Biological Medicinal Products Containing Recombinant Human Growth Hormone: European Regulation

Published:2007-12-04 Issue:1 Volume:69 Page:14-21
ISSN:1663-2818
Container-title:Hormone Research in Paediatrics
language:en
Short-container-title:Horm Res Paediatr

Author:

Pavlovic Mira,Girardin Elizabeth,Kapetanovic Liliana,Ho Kowid,Trouvin Jean-Hugues

Publisher

S. Karger AG

Subject

Endocrinology,Endocrinology, Diabetes and Metabolism,Pediatrics, Perinatology and Child Health

Reference27 articles.

1. Directive 2004/27/CE du Parlement Europeen et du Conseil, du 31 mars 2004; Directive 2001/83/EC, as amended by Directives 2003/63/EC and 2004/27/EC.

2. Guideline on Similar Biological Medicinal Products. CHMP/437/04 (CHMP adopted September 2005).

3. Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues. EMEA/CHMP/BWP/49348/05 (CHMP adopted February 2006).

4. Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues. EMEA/CHMP/42832/05 (CHMP adopted February 2006).

5. Annex Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues - Guidance on Similar Medicinal Products Containing Somatropin. EMEA/CHMP/94528/05 (CHMP adopted February 2006).

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