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Guideline on the clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis (ALS)

We have adopted this International Scientific Guideline -EMA/531686/2015, Corr.1

Last updated

About this guideline

Overseas effective date:  1 June 2016

Replaces: CPMP/EWP/565/98 Points to Consider on Clinical Investigation of Medicinal Products for the Treatment of Amyotrophic Lateral Sclerosis (ALS) (adopted by TGA 23 February 2001)

Categories: Clinical efficacy and safety | Nervous system

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.

For more information see International scientific guidelines adopted in Australia.

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