no originator = no generic [Regulatives / Guidelines]
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
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
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- EU reference product - no originator available nobody 2016-04-27 09:22 [Regulatives / Guidelines]
- No EU originator available: bad luck Helmut 2016-04-27 11:38
- No EU originator available: bad luck nobody 2016-04-27 12:01
- no originator = no genericDr_Dan 2016-04-27 15:42
- no originator = no generic nobody 2016-04-27 16:31
- No EU originator available: bad luck Helmut 2016-04-27 11:38