NOTE FOR GUIDANCE ON THE CLINICAL REQUIREMENTS FOR LOCALLY APPLIED, LOCALLY ACTING PRODUCTS CONTAINING KNOWN CONSTITUENTS

Adopted by the TGA: 28 October 2011

Overseas effective date: 1 June 1996

Categories: Clinical efficacy and safety | clinical pharmacology and pharmacokinetics| Clinical efficacy and safety | General

TGA annotations: 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.

• 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.
• All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information. 

For more information see International scientific guidelines adopted in Australia