Comments to CHMP Guideline on Similar Biological Medicinal Products containing
Non-clinical and clinical issues (EMEA/CHMP/42832/2005)
In May 2005 the EMEA Committee for Medicinal Products for Human Use (CHMP) issued for public consultation a draft Guideline on “Similar Biological Medicinal Products containing biotechnology- derived proteins as active substances: Non-Clinical and Clinical Issues”.
EBE, the Emerging Biopharmaceutical Enterprises group, directly represents 69 biopharmaceutical companies – mainly Small & Medium-sized Enterprises – in Europe, which are researching and developing new treatments using biotechnological methods. Therefore, EBE members particularly welcome the EMEA and CHMP’s initiative to consult all interested parties on this draft Guideline and are pleased to be able to contribute to this document providing general and more specific comments in the following pages.
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