ICH topic Q6B - Specifications: test procedures and acceptance criteria for biotechnological/biological products

We have adopted this International Scientific Guideline – ICH Q6B; CPMP/ICH/365/96

Last updated

10 January 2025

About this guideline

Overseas effective date: September 1999

Categories: ICH | Quality

Biologicals | Active substance

Biologicals | Finished product

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.

Product types