EMA Stresses Brevity, Relevance in Update to SmPC Guidance

March 4, 2013
The European Medicines Agency (EMA) issued additional advice for drugmakers on how to prepare and update a summary of product characteristics (SmPC). SmPCs are included as part of the marketing authorization for all medicines and are updated throughout the drug’s lifecycle, especially when new data emerge on safety and efficacy.
International Pharmaceutical Regulatory Monitor