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Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture

We have adopted this International Scientific Guideline - EMA/CHMP/BWP/368186/2011

Last updated

 

About this guideline

Adopted by the TGA: 24 February 2014

Overseas effective date: 11 February 2012

Replaces: In place of concept paper EMEA/CHMP/BWP/481473/2008

Categories: Multidisciplinary | Vaccines 

TGA annotations:

Effective 1 November 2014: the Quality aspects of this Guideline are replaced by EMA/CHMP/BWP/310834/2012 Guideline on Influenza Vaccines - Quality Module.

The nonclinical and clinical aspects of this Guidelines continue to apply.

nonclinical and clinical aspects of this Guidelines continue to apply. 

  • 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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