Clinical investigation of medicinal products for long-term use

We have adopted this International Scientific Guideline - pp. 127 - 132 of Rules 1998 (3C) - 3CC6a.

Last updated

3 June 2024

About this guideline

Overseas effective date: August 1987

Replaces: pp. 163 - 165 of Rules 1989

Categories: Clinical efficacy and safety | General

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.
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.