For Generics, EU Reference Product Is Non-Negotiable – Even In Pilot On Parallel Advice

 
• By Urtė Fultinavičiūtė

Acknowledging that it may be a barrier to some extent, EMA’s senior scientific specialist of clinical pharmacology Kevin Blake notes that EU reference medicinal products are a legal requirement for bioequivalence studies and cannot be circumvented.

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• Source: Shutterstock

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