Bioequivalence and Bioavailability Forum

Dear qualityassurance,

❝ In case FDC (two active ingredients) with ascorbic acid is not approved in Europe. However, FDC (two active ingredients) is approved. In case if we want to apply for FDC (two active ingredients) with ascorbic acid in Europe, is it needed to conduct any safety and efficacy study in patients or only BE study will be enough justifying that ascorbic acid is used as an excipient?

I am not sure that I fully understand what you are trying to achieve here.

If ascorbic acid is indeed only used as excipient (e.g. as antioxidant), and you are not intending to put it on the list of active substances: a BE study should be enough in module 5. You will have to justify the use of ascorbic acid in module 3, including the amount used, just like any other excipient.

If you're just trying to disguise ascorbic acid as an excipient to make your life easier, but the quantity is not consistent with that use (500 mg won't do), or if you try at the same time to mention it on the SmPC elsewhere than just the list of excipients: this won't do, and you will have to provide justifications in module 5. Difficult to say which without knowing what your two active ingredients are. Could be limited to bibliography (well-established use), could need to provide more.