ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/ biological entities)

We have adopted this International Scientific Guideline – ICH Q11; EMA/CHMP/ICH/425213/2011

About this guideline

Overseas effective date: November 2012

Categories: ICH | Quality

Quality | Active substance

Biologicals | Active substance

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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