IPEC e-newsletter - Excipients Insight June 2018 - 19-06-18

 

Inside this issue

     

EMA starts new consultation on ICH Q3D

The European Medicines Agency (EMA) has opened a new consultation on ICH Q3D Elemental Impurities – which extends to 16 August. The intention is to carry out some minor housekeeping to the guidance, including error correction of the permitted daily exposure (PDE) for Cadmium by the inhalation route from 2µg/day to3 µg/day, and does not include any significant changes.

For reference, the new consultation document appears here.

 

 

 

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