ICH topic Q 5 E - Comparability of biotechnological/ biological products

We have adopted this International Scientific Guideline – ICH Q5E; CPMP/ICH/5721/03

About this guideline

Overseas effective date: June 2005

Categories: ICH | quality

Biologicals | Active substance | Comparability/biosimilarity

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.
All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.