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Guideline on clinical evaluation of new vaccines

We have adopted this International Scientific Guideline - EMEA/CHMP/VWP/164653/2005.

Last updated

About this guideline

Overseas effective date: 1 February 2007

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

Categories: Multidisciplinary | Vaccines 

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.

  • 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.

For more information see International scientific guidelines adopted in Australia.

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