ICH Topic M4S - Common technical document for the registration of pharmaceuticals for human use - safety

We have adopted this International Scientific Guideline – ICH M4S; CPMP/ICH/2887/99 - Safety

Overseas effective date: July 2003

Categories: ICH | 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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