EMA example [Design Issues]

posted by mittyri – Russia, 2019-11-21 11:38 (471 d 11:49 ago) – Posting: # 20851
Views: 3,124

Hi Pharmcat,

» If we continue, in paragraph 57 we find: it is necessary to provide documentation on the clinical use of the appropriate drugs in combination or through clinical trials, or published literature, or a combination of both. These data should argue the basis for the combined use of active substances. To establish a positive benefit-risk combination, it is not enough to exclusively provide data on the combined use of single-component drugs.

Please cite from the beginning: As noted in chapters 5.3.1 and 5.3.3.
So that point explains different scenarios.

» When you submitting a dossier you should indicate is it a reference drug or generic. It your drug is generic - you should find reference drug (single drug) - scenario 1. It you indicate yours drug as reference and want to do only one bioequivalnce trial you should provide data of using in combination and interaction ets., some time it can be done when FDC already registered in other regulations. Usually not enough to perform only BE study.

From your logic scenario 5.3.2 does not exist in principle :-) You pointed that doc by your self.

» And than, "If say strict - both cases is wrong." - scenarion 1.

That's your point of view only and it is not supported by any docs or examples in Russia. As Beholder noticed above, the statement for generic drug in law could be interpreted more broader (as our experts do)

» If new FDC have registration history and completely safety and efficacy data - it can be very individual case

Is that example from EMA jurisdiction also an 'individual case'?

» FDC registration procedure is a gray zone also. And if the sponsor approaches responsibly to high-quality development - the sponsor will not use the gray zone of legislation.

Nothing grey here, just follow the common sense and real practice. If the sponsor has the Legal Clinical data from not fixed combination and performed BEQ studies - that's enough, not only in Russia as I showed above.

Kind regards,

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