Bioequivalence and Bioavailability Forum

Hi nobody,

❝ Wanna do a BE trial for EU, but there is no orignator's product on the market (any more), what is the solution?

Too bad. See the BE-GL Section 4.1.2 and the referred Directive 2001/83/EC Article 8.
I once succeeded with a reference product which was registered in a member state of the EEA (Switzerland) – but it was a hell of paper work and a hybrid application (PK + clinical study). Don’t think that it would be acceptable in ‘pure’ BE.

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