Concept paper on a guideline on the chemical and pharmaceutical quality documentation concerning biological investigational medicinal products in clinical trials

We have adopted this International Scientific Guideline - EMEA/CHMP/BWP/466097/2007.

Last updated

3 June 2024

About this guideline

End of consultation (overseas): 31 May 2008

Categories: Biologicals | Finished product | Investigational medicinal products

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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