Adoption/non-adoption of European Union guidelines in Australia
Consultation
The EU guidelines below have been recommended for adoption or non-adoption by the TGA. These guidelines are open for comment on whether or not they should be adopted in Australia. Please note the date of closure for comment varies from guideline to guideline.
Submission of comments
Your comments on the proposed adoption or non-adoption of these EU guidelines, particularly your advice on whether you support the proposed action, would be appreciated.
Comments may be sent by email or mail and should include your full contact details.
The email address for comments is: Euguidelines@tga.gov.au
The postal address for comments is:
Ministerial and Project Group
MDP 122
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
Australia
Guidelines proposed for adoption
Closing date for comments: 24 July 2009
- EMEA/CHMP/BWP/157653/2007 (pdf,117kb)
Guideline on Development, Production, Characterisation and Specifications for Monoclonal Antibodies and Related Products
- "Sponsors should note that in respect of Section 4.2.3 (which relates to Viral Safety and Transmissible Spongioform Encephalopathy), the guidelines TGA Approach to Minimising the Risk of Exposure to Transmissible Spongiform Encephalopathies (TSEs) Through Medicines and Supplementary requirements for therapeutic goods for minimising the risk of transmitting transmissible spongiform encephalopathies (TSEs) are relevant to assessment in Australia."
- EMEA/CPMP/VEG/4717/2003- Rev 1 (pdf,128kb)
Guideline on Dossier Structure and Content for Pandemic Influenza Vaccine Marketing Authorisation Application (Revision) - EMEA/49993/2008 (pdf,91kb)
CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context - EMEA/CHMP/BWP/48316/2006 (pdf,82kb)
Guideline on the Quality of Biological Active Substances Produced By Stable Transgene Expression in Higher Plants - EMEA/CHMP/BMWP/118264/2007 (pdf,63kb)
Guideline on Non-Clinical and Clinical Development of Similar Biological Medicinal Products Containing Low-Molecular-Weight Heparins
Guidelines proposed for non-adoption
- Nil