EMA Adopts New Guidelines for Monitoring Biologics and Biosimilars

The European Medicines Agency (EMA) has adopted a new chapter to its guidelines on good pharmacovigilance practices (EU-GVP), entitled “Product- or population-specific considerations II: Biological medicinal products”.

Biological medicines are those which have an active ingredient which was derived from a living organism whereas biosimilars are medicines that are developed to be similar to an existing “reference medicine”.

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Published 16. August 2016 in News EU