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

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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A recent webinar on the FDA-EMA parallel scientific advice (PSA) program for complex generics aimed to increase sponsor interest in the program, but also included some blunt acknowledgements about why it has so far not drawn many participants.

EMA’s senior scientific specialist of clinical pharmacology Kevin Blake began his session – titled “EMA and International Engagement for Generics...