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
