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EMA Consults On SmPC Content Relating To Pharmacodynamic Properties

 
• By Vibha Sharma

The European Medicines Agency is consulting on how drug assessors can ensure that information submitted by sponsors on their drug’s pharmacodynamic properties is limited to what is relevant to a prescriber.

Person reading patient instruction leaflet at the tablets and glass of water
SmPC forms the basis for the safe and effective use of a medicine by health care providers • Source: Shutterstock

The European Medicines Agency is inviting stakeholder feedback on a draft guideline that sponsors can refer to when preparing a summary of product characteristics (SmPC) document for regulatory review to ascertain what information to include on a drug’s pharmacodynamic properties.

While the draft guideline is meant for drug assessors who review SmPC documents submitted in relation to medicines evaluated via...

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