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
- EMEA/CHMP/ICH/437986/2006 (pdf,46kb)
Note for Guidance on Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
- EMEA/CHMP/EWP/517497/2007 (pdf,48kb)
Guideline on Clinical Evaluation of Medicinal Products Used in Weight Control (Cpmp/Ewp/281/96 Rev. 1)
Addendum on Weight Control in Children
Guidelines proposed for non-adoption
- Nil