Pharma Worried By EMA’s Stricter Approach To New Active Substance Claims For Biologics

 
• By Vibha Sharma
  
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EFPIA says the European Medicines Agency’s proposed criteria for determining “new active substance” status for biologicals may encourage subjective assessments and result in a higher standard for grant of the status. 

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NAS status is important for companies to protect their drug from generic competition for several years • Source: Shutterstock

Research-based drug companies in the EU are concerned that the European Medicines Agency may be heading towards taking a stricter approach to assessing whether active substances in biological medicines qualify as a “new active substance” (NAS).

Key Takeaways

  • The European Federation of Pharmaceutical Industries and Associations has expressed strong concern over a draft reflection paper issued last year to describe the latest scientific thinking of EU regulators while assessing whether active substances in biologicals qualify as a new active substance (NAS).

Their concerns are in response to a draft EMA reflection paper, issued for stakeholder consultation last year, on the criteria...

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