Clinical investigation of medicinal products for the treatment of gout
Table of contents
The main aim of the guideline is to address general guidance on the development of medicinal products for the treatment of gout. This guideline should be read in conjunction with other EMA and ICH guidelines, which may apply to these conditions and patient populations.
Keywords: gout, urate lowering therapy, tophi, chronic tophaceous arthropathy.
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Guideline on clinical investigation of medicinal products for the treatment of gout - First version (PDF/324.06 KB)
Adopted
First published: 14/11/2019
Legal effective date: 01/06/2020
EMA/CHMP/774470/2018 -
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Draft guideline on clinical investigation of medicinal products for the treatment of gout - First version (PDF/331.79 KB)
Draft: consultation closed
First published: 08/02/2019
Last updated: 07/08/2019
Consultation dates: 08/02/2019 to 31/08/2019
EMA/CHMP/774470/2018 -
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Concept paper on the need of the guideline on clinical investigation of medicinal products for the treatment of gout - First version (PDF/103.94 KB)
Draft: consultation closed
First published: 14/06/2012
Last updated: 14/06/2012
Consultation dates: 14/06/2012 to 30/09/2012
EMA/CHMP/937321/2011