Seasonal influenza vaccines - quality module
Explanatory document for the EMA guideline on influenza vaccine
Version 1.0, August 2017
TGA has published an explanatory document to support the submission of quality modules as part of registration applications for influenza vaccines (Category 1 applications), and/or variation applications for annual strain updates to seasonal influenza vaccines (Category 3 applications). TGA adopted the EMA Guideline on Influenza Vaccines - Quality Module (EMA/CHMP/BWP/310834/2012) on 1 November 2014. The quality modules submitted to TGA are expected to meet this EMA guideline.
Sponsors are invited to provide comment on this document by 26 October 2017 (8 weeks from publication date).
Please contact us via email at Vaccines@health.gov.au