Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle-stimulating hormone (r-hFSH)

We have adopted this International Scientific Guideline - EMA/CHMP/BMWP/671292/2010.

Last updated

4 June 2024

About this guideline

Overseas effective date: 1 September 2013

Categories: Multidisciplinary | Biosimilar | Product-specific biosimilar guidelines

TGA annotations: Nil

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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