TGA
Earlier this year we conducted a on whether we should adopt certain international scientific guidelines. Following an extensive internal and external consultation process, we have adopted the following 13 international scientific guidelines:
- (ICH M9; EMA/CHMP/ICH/493213/2018)
- (ICH S11)
- – Addendum (ICH E11(R1); EMA/CPMP/ICH/2711/1999)
- (ICH S1B(R1); EMA/774371/2022)
- (FDA-2019-D-0359)
- – Implementation Guide v1.5 (ICH M8 Expert Working Group)
- (EMA/CHMP/205/95 Rev. 5)
- (ICH E8 (R1); EMA/CHMP/ICH/544570/1998 Corr*)
- (ICH Q3C (R8); EMA/CHMP/ICH/82260/2006 Corr.*)
- (ICH M7 (R2); EMA/CHMP/ICH/83812/2013)
- (ICH M7 (R2); EMA/CHMP/ICH/5072766/2021)
- (ICH M10; EMA/CHMP/ICH/172948/2019)
- (ICH Q3D (R2); EMA/CHMP/ICH/353369/2013)
While International Scientific Guidelines that are adopted in Australia are not mandated by legislation, they are intended to provide advice to applicants and/or sponsors to assist them in meeting legislative requirements. This includes the most appropriate way to interpret and fulfil the obligations to demonstrate safety, quality and efficacy as set out in the Therapeutic Goods Act 1989. This advice represents a harmonised approach and is based on the most up-to-date scientific knowledge.
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