ICH M4Q Common technical document for the registration of pharmaceuticals for human use - quality

We have adopted this International Scientific Guideline – ICH M4Q; CPMP/ICH/2887/99

Last updated

12 December 2024

About this guideline

Adopted by the TGA: 28 February 2020

Overseas effective date: July 2003

Categories: ICH | Multidisciplinary

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

Topics