Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Revision 2

About this guideline

Adopted by the TGA: 24 May 2026

Overseas effective date: 27 January 2022

Replaces: Concept paper on a guideline on the chemical and pharmaceutical quality documentation concerning biological investigational medicinal products in clinical trials (EMEA/CHMP/BWP/466097/2007)

Categories: Biologicals | Finished product | Investigational medicinal products

TGA annotations: Where this TGA adopted EMA guideline cross references other EMA guidance documents that have not been adopted by the TGA, those documents are provided for general regulatory information only and do not represent TGA adopted requirements. Sponsors should contact the TGA for further advice where reliance on such guidance is proposed.

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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For more information see International scientific guidelines adopted in Australia.