Reflection paper: non-clinical and clinical development of similar medicinal products containing recombinant interferon alfa

We have adopted this International Scientific Guideline - EMEA/CHMP/BMWP/102046/2006

Last updated

24 December 2024

Adopted by the TGA: 17 December 2010

Overseas effective date: 1 April 2009

Categories: Multidisciplinary | Biosimilar

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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