Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products
This document aims to provide guidance on how to present the application for registration of traditional herbal medicinal products (THMPs) in the Common Technical Document (CTD) format, providing information to help the applicant in their submissions.
Keywords: Herbal medicinal products (HMPs) ; traditional herbal medicinal products (THMPs); CTD; traditional use simplified registration; HMPC
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Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products- Revision 2 (PDF/1.15 MB)
Adopted
First published: 27/06/2016
Last updated: 27/06/2016
EMA/HMPC/71049/2007 -
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Overview of comments received on guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products-Revision 2 (PDF/340.9 KB)
Adopted
First published: 27/06/2016
Last updated: 27/06/2016
EMA/HMPC/669906/2015 -
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Draft guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - Revision 2 (PDF/1.31 MB)
Draft: consultation closed
First published: 09/04/2015
Last updated: 09/04/2015
Consultation dates: 09/04/2015 to 15/07/2015
EMA/HMPC/71049/2007 Rev. 2 -
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Concept paper on the need to update the note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders and the note for guidance on the clinical investigation on hypertension - Revision 4 (PDF/40.44 KB)
First published: 23/07/2009
Last updated: 23/07/2009
EMEA/CHMP/EWP/350495/2009
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Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - Revision 1 (PDF/316.78 KB)
Adopted
First published: 13/05/2013
Last updated: 13/05/2013
EMA/HMPC/71049/2007 Rev. 1 -
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Overview of comments received on guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - Revision 1 (PDF/160.33 KB)
First published: 13/05/2013
Last updated: 13/05/2013
EMA/HMPC/768094/2012 -
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Draft guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - Revision 1 (PDF/312.96 KB)
Draft: consultation closed
First published: 08/08/2012
Last updated: 08/08/2012
Consultation dates: 08/08/2012 to 15/10/2012
EMA/HMPC/71049/2007 Rev. 1 -
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Concept paper on the revision of the guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - Revision 1 (PDF/70.96 KB)
Draft: consultation closed
First published: 01/06/2011
Last updated: 01/06/2011
Consultation dates: 31/03/2011 to 15/09/2011
EMA/HMPC/111298/2011
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Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - First version (PDF/119.09 KB)
Adopted
First published: 10/01/2008
Last updated: 10/01/2008
Legal effective date: 10/01/2008
EMEA/HMPC/71049/2007 -
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Overview of comments received on draft guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - First version (PDF/73.48 KB)
First published: 10/01/2008
Last updated: 10/01/2008
EMEA/HMPC/539645/2007