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Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections

We have adopted this International Scientific Guideline - CPMP/EWP/558/95 rev 2

Last updated

About this guideline

Overseas effective date:  15 January 2012

Replaces: EMEA/CHMP/EWP/435635/2008 concept paper on this topic (provided for information 1 May 2009)

Categories: Clinical efficacy and safety | Anti-infectives for systemic use

TGA annotations:

The Report of the Joint Expert Advisory Committee on Antibiotic Resistance (1999) accepted by the Commonwealth, also includes recommendations for assessment of the propensity for promoting resistance and cross-resistance.

  • 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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