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Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis

We have adopted this International Scientific Guideline - CHMP/EWP/2454/02 corr.

Last updated

About this guideline

Overseas effective date: June 2005

Categories: Clinical efficacy and safety | Dermatologicals

TGA annotations:

Section 5.2.5 on this guideline suggests that regulatory approval requires a comparison with an active comparator (e.g. cyclosporin, methotrexate etc). Placebo-controlled studies may also be acceptable 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.
  • 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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