EEU FDC Scenario 5.3.2 [Design Issues]

posted by PharmCat  – Russia, 2019-11-20 16:39 (1560 d 02:35 ago) – Posting: # 20841
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❝ The discussed FDCs are explained as a scenario 5.3.2

❝ point 56 says that bridging studies are required comparing FDC with concomitant monodrugs administration along the bioequivalence justification

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.

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.

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

If new FDC have registration history and completely safety and efficacy data - it can be very individual case and make certain recommendations without a clear understanding also can be not correct.

❝ Is that a crime? Russian courts mainly say no.

It is a gray zone I think. 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.

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