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INDUSTRY:

Pharma

TOPIC:

Research & Development

TITLE:

EMA: Draft guideline on non-clinical documentation in applications for marketing authorization/registration of well-established and traditional herbal medicinal products - Revision 1

BRIEF:

This guideline provides guidance on the minimum requirements for non-clinical data for well- established herbal medicinal products in bibliographical applications for marketing authorizations and on the question which non-clinical safety aspects should be addressed in the expert report for the simplified registration of traditional herbal medicinal products and which additional non-clinical safety tests might be necessary to prove safety. The guideline may also be used in the framework of assessment for establishment of a EU herbal monograph or an entry into the list of traditional herbal substances.

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