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Guideline on clinical evaluation of medicinal products used in weight management

We have adopted this International Scientific Guideline - EMA/CHMP/311805/2014.

Last updated

About this guideline

Overseas effective date: 1 January 2017

Replaces: CPMP/EWP/281/96 Rev. 1 Guideline on Clinical Evaluation of Medicinal Products Used in Weight Control (Adopted by TGA 26 March 2010)

Categories: Clinical efficacy and safety | Alimentary tract and metabolism

TGA annotations:

If a sponsor wishes to claim secondary benefits associated with weight loss (such as improved blood lipids, glycaemic control or blood pressure), then the relevant guidelines for these specific benefits should be independently satisfied.

  • 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.

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