Reflection paper on the dissolution specification for generic solid oral immediate release products with systemic action

We have adopted this International Scientific Guideline - EMA/CHMP/CVMP/QWP/336031/2017

Last updated

24 December 2024

Adopted by the TGA: 8 June 2023

Overseas effective date: 10 August 2017

Categories: Quality | Non-immunologicals | Specifications, analytical procedures and analytical validation

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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