Annex 15

Consultations on adoption of EU guidelines in Australia

EU guidelines

A number of EU guidelines have been proposed for adoption or non-adoption by the TGA. These are now open for comment until 19 August 2013. The guidelines in question are listed below:

  • Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture.
  • Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials
  • ICH guideline Q4B annex 7 (R2) to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on dissolution test. General chapter. Step 5
  • ICH guideline S2 (R1) on genotoxicity testing and data interpretation for pharmaceuticals intended for human use – Step 5
  • Question and answers on the ‘Note for guidance on photosafety testing’
  • Questions and answers on the withdrawal of the ‘Note for guidance on single dose toxicity’
  • Guideline on repeated dose toxicity
  • Questions and answers on the ‘Guideline on the limits of genotoxic impurities’

Further information can be found on the TGA website at here

Read more on similar topics here and here.