Qualification of novel methodologies for drug development: guidance to applicants (EMA/CHMP/SAWP/72894/2008). 2013

Published by EMA

Scientific AdviceEMA Qualification

The EMA Qualification process is a new, voluntary, scientific pathway leading to either a CHMP Qualification opinion or a qualification advice on innovative methods or drug development tools

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The European Medicines Agency publishes scientific guidelines on human medicines that are harmonised by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

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REGULATION (EC) No 847 2000

Published by EMA

Orphan Medicinal ProductProvision

This document is the COMMISSION REGULATION (EC) No 847/2000
of 27 April 2000
laying down the provisions for implementation of the criteria for designation of a medicinal
product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’
and‘clinical superiority’

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