Guideline on the clinical evaluation of medicinal products indicated for the prophylaxis or treatment of respiratory syncytial virus (RSV) disease

We have adopted this International Scientific Guideline - EMA/CHMP/257022/2017

Adopted by the TGA: 28 February 2020

Overseas effective date: 1 May 2019

Categories: Clinical efficacy and safety | Anti-infectives for systemic use

Multidisciplinary | Vaccines (multidisciplinary)

TGA Annotations: Nil

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.
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Product types

Product regulation