EMA Makes A Case For Focused Guidance On Nasal Products

 
• By Vibha Sharma
  
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A draft reflection paper by the European Medicines Agency points to the lack of consensus or guidance when it comes to demonstrating therapeutic equivalence between nasal products intended for local treatment.

Rhinitis nose low poly . Treatment nasal medicine coryza. Pharmacy runny nose spray. Polygonal design banner template vector illustration
Nasal products can be for local or systemic treatment • Source: Shutterstock

The European Medicines Agency is inviting stakeholder feedback on its proposal for a new guidance document that explains what data are needed from sponsors to demonstrate therapeutic equivalence between nasal products containing the same active moieties.

Key Takeaways

  • The European Medicines Agency has identified the need for a guideline specifically on therapeutic equivalence (TE) for nasal medicinal products.

The topic is not sufficiently covered in existing guidelines, the EMA said, adding that a new guidance document would help...

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