International scientific guideline: Note for guidance on the clinical requirements for locally applied, locally acting products containing known constituents

About this guideline

Overseas effective date: 1 August 1997

Categories: Clinical efficacy and safety | General (clinical)

Replaces: CPMP/EWP/239/95

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TGA annotations

The following explanatory note was added on 28 October 2011:

The TGA does not consider this guideline to be applicable to applications seeking the registration of eye drops that exert their effect beyond the cornea (i.e. the deeper tissues of the eye). Examples of such eye drops include eye drops for the treatment of glaucoma.

Requirements for establishing the bioequivalence of such eye drops to an innovator product are set out in the EU guideline Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1) that has been adopted.

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.