no originator = no generic [Regulatives / Guidelines]

posted by Dr_Dan  – Germany, 2016-04-27 17:42 (3210 d 01:13 ago) – Posting: # 16250
Views: 2,658

Dear nobody
In applications for generic medicinal products according to Directive 2001/83/EC, Article 10(1) bioequivalence needs to be demonstrate between the generic medicinal product and a reference medicinal product in order to allow bridging of preclinical tests and of clinical trials associated with the reference medicinal product. How do you want to make a reference if no originator exists? In such a case you have to provide pre-clinical and clinical data for safety and efficacy.
I hope this helps
Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan

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