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Guideline on quality, non-clinical and clinical ...
www.ema.europa.eusystem may also compromise the approval of the clinical trial if the safety of trial subjects is at risk. 117 Changes during the clinical trial 118 Where changes to the clinical trial dossier become necessary during an ongoing clinical trial, it is the
Guideline on similar biological medicinal products ...
www.ema.europa.euGuideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
MEDICINES CONTROL COUNCIL - mccza.com
www.mccza.comRegistration of Medicines Biosimilars . MEDICINES CONTROL COUNCIL. BIOSIMILAR MEDICINES QUALITY, NON-CLINICAL AND CLINICAL REQUIREMENTS