BEQ study between different strengths [Regulatives / Guidelines]

posted by Dr_Dan  – 2017-01-16 17:40 (1738 d 01:07 ago) – Posting: # 16958
Views: 3,429

Dear Aga
Definition of generic Drug: same API, same route of adminsitration, same strength(s)
In consequence your test product is no generic product according to Article 8(3) 2001/83/EC = no generic application. However, you can submit your product as a hybrid application.

Hybrid applications under Article 10(3) of Directive 2001/83/EC differ from generic applications in that the results of appropriate pre-clinical tests and clinical trials will be necessary in the following three circumstances:In such cases the results of tests and trials must be consistent with the data content standards required in the Annex to the Directive 2001/83/EC as amended by Directive 2003/63/EC.
These applications will thus rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data. Some guidance on the appropriate additional studies required is indicated in Annex IV of the Chapter 1 of the Notice to Applicants.
The type of applications mentioned above refer to information that is contained in the dossier of the authorisation of the reference medicinal product, for which a marketing authorisation has been granted in the Union on the basis of a complete dossier in accordance with article 8(3), 10a, 10b or 10c of Directive 2001/83/EC.

If you can demonstrate bioequivalence between your 40 mg-test product given twice (i.e. 80 mg dose) vs 80 mg-reference and if the test product is intended to be given in the same dose as the reference you will not need to provide additional data.

I hope this helps.

Kind regards and have a nice day

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