Considerations given to designation of a single stereo isomeric form (enantiomer), a complex, a derivative, or a different salt or ester as new active substance in relation to the relevant reference active substance - Scientific guideline

This document outlines the scientific approach to evaluate whether enantiomers, complexes, derivatives or different salts or esters of an existing active substance should be considered as a new active substance.

Keywords: New active substance, enantiomers, complex, derivative, salt, ester, reference active substance

Current effective version

Reflection paper on considerations given to designation of a single stereo isomeric form (enantiomer), a complex, a derivative, or a different salt or ester as new active substance in relation to the relevant reference a...

Adopted Reference Number: EMA/651649/2010 Summary:

The scope of this paper is restricted to consideration of differences between a single enantiomer, a complex, a derivative or a different salt or ester and the corresponding reference active substance. The questions being addressed are “when should such an active substance be regarded as a new active substance (NAS) in relation to the relevant reference active substance and what level of evidence would be required to confirm the designation as a new active substance”?

Document history

Overview of comments received on 'reflection paper on considerations given to designation of a single stereo isomeric form (enantiomer) as new active substance in relation to a reference active substance which is a racem...

Reference Number: EMA/355542/2011

Draft reflection paper on considerations given to designation of a single stereo isomeric form (enantiomer) as new active substance in relation to a reference active substance which is a racemic mixture of enantiomers

Draft: consultation closed Consultation dates: 18/11/2010 to 28/02/2011 Reference Number: EMA/651649/2010 Summary:

The scope of this paper is restricted to consideration of differences in isomeric composition of a product compared to a racemic reference active substance. The question being addressed is “when should an enantiomer be regarded as a new active substance (NAS) in relation to a reference active substance which is a racemate and what level of evidence would be required to confirm the designation as a new active substance”?