Regulatory Submission in Europe in Absence of Reference product [Regulatives / Guidelines]

posted by dshah – India/United Kingdom, 2021-03-23 09:51 (255 d 02:03 ago) – Posting: # 22290
Views: 6,312

Hi Abhay Patil!
In absence of Innovator product in EU and UK market for FDC, you may have to do BE against individual drug substance innovator product. Please see Guideline on clinical development of fixed combination medicinal products.
Regards,
Dshah

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