International scientific guideline: Guideline on dossier structure and content for pandemic influenza vaccine marketing authorisation application (Revision)

About this guideline

Overseas effective date: 1 Apr 2014

Replaces: CPMP/VEG/4717/03 (Adopted by TGA 16 August 2004)

Categories: Biological medicines | Drug substance | Multidisciplinary | Vaccines (multidisciplinary) | Nonclinical | General (nonclinical)

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TGA annotations

Section 1.1.2. Pandemic variation

If the pandemic influenza virus is of a HN subtype for which nonclinical and clinical data have not been included in the Core Pandemic Dossier, it is highly desirable that nonclinical and clinical data obtained from studies with the pandemic HN subtype be included in the pandemic variation dossier.

Section 3.1.1

Candidate influenza vaccine virus should be taken to include the most recently available candidates and technologies, as noted on WHO website(link is external).

Effective 1 November 2014: the Quality aspects of this Guideline are replaced by EMA/CHMP/BWP/310834/2012 Guideline on Influenza Vaccines - Quality Module.

The nonclinical and clinical aspects of this Guidelines continue to apply.

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For more information see International scientific guidelines adopted in Australia.

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.