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Guideline on summary of requirements for active substances in the quality part of the dossier

We have adopted this International Scientific Guideline - CHMP/QWP/297/97 Rev 1 corr, EMEA/CVMP/1069/02 

Last updated

About this guideline

Overseas effective date: 1 February 2005 

Replaces: CHMP/QWP/297/97 (adopted by TGA 12 February 2003)

Categories: Quality | Non-immunologicals | Active substance
 

TGA annotations

The pharmacopoeias of EU member states, other than the British and European Pharmacopoeias (BP and Ph Eur), have no standing in Australia. The official standards in Australia are the British Pharmacopoeia (BP), the European Pharmacopoeia (Ph Eur) and the United States Pharmacopeia-National Formulary (USP).

Additional TGA requirements for active substances, Drug Master Files and Certificates of Suitability are set out in the Australian Regulatory Guidelines for Prescription Medicines.

  • 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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