International scientific guideline: Guideline on clinical evaluation of new vaccines

About this guideline

Overseas effective date: 6 Jan 2009

Replaces: CPMP/EWP/463/97 Note for Guidance on Clinical Evaluation of New Vaccines (Adopted by TGA 6 February 2002)

Categories: Multidisciplinary | Vaccines (multidisciplinary)

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TGA annotations

Sponsors in Australia should provide data on the consistency of full scale manufacturing lots in respect of clinical safety and efficacy (immunogenicity) or justify the absence of such data.

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For more information see International scientific guidelines adopted in Australia.

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.