
TY  - JOUR
A1  - Grohmann, Gary 
T1  - Regulatory issues in pandemic influenza vaccine development
JF  - Microbiology Australia
JO  - Microbiol. Aust.
Y1  - 2006
VL  - 27
IS  - 4
SP  - 172
EP  - 174
KW  - 
UR  - https://doi.org/10.1071/MA06172 
N2  - The Therapeutic Goods Administration (TGA) is responsible for the licensing of vaccines used in Australia. This includes pre-market evaluation aspects (such as assessing the quality, efficacy and safety of vaccines) and post-market aspects (such as batch release testing and the monitoring of adverse reactions). For inter-pandemic and pandemic influenza vaccines, TGA is also involved in the selection of appropriate vaccine viruses and the calibration and supply of reagents for the production of influenza vaccines. Together with industry, TGA has a responsibility to ensure that all regulatory and good manufacturing requirements (GMP) are met to ensure vaccine safety and efficacy. 
ER  -

