EEU FDC Scenario 5.3.2 [Design Issues]

posted by mittyri – Russia, 2019-11-20 11:32  – Posting: # 20836
Views: 742

Hi Pharmcat,

» But we know that sometimes "FGBU" using EMA/FDA guidelines in expertise.

Sometimes yes, sometimes not. Do you know what are the requirements for the registration of generic MR products? Do you know what are the differences with EMA/FDA? I can assure you, experts also know that.

» » Do you have any links to the upcoming drafts or some mentions?
» Here

OK, that document links to this one
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
So we see in this scenario that PD studies are not required (till the moment the Sponsor wants to change some dosage or regimen), PK studies are going ALONG the bioequivalence study, so it could be done in one stage.
Tricky moment is clinical justification (p.57-58), but if the scientific evidence is good enough (tons of links), I don't think there could be a problem. If and only if there are no clinical studies performed before using such a combination, additional clinical studies should be requested. In other situations it is possible if the expert decides that there's not enough data explaining efficacy/safety, benefit/risk ratio.

» So, if this new drug, hence not a generic, hence no bioequivalence as a registration trial.

Generic is also a new drug since only the API is the same :-)
That's why the law admits simplified procedure in such cases.

» Why I can't really think that some drugs was registered illegal or with abusing? I saw successful bioequivalence trial of atorvastatin with 18 volunteers. :-D

That's a drawback of our expertise/inspection system and it is not related to the current topic. All BEQ studies required for registration could be performed within a high quality standard.
Even with EEU I showed that the criteria could be met with BEQ study(ies) only when the clinical data is available.

» It should be understood that for such drugs (even if it was possible to justify bioequivalence) at the time of re-registration all the missing data (efficacy, safety) may be requested as for the reference drug.

Yes, it could be requested if they are not presented in dossier. Tricky point is the data privacy - does that Sponsor have rights to use that clinical data? Are they copyrighted?
You know current state of affair: to stimulate the market the authorities in Russia admit the usage of clinical data in dossier of other Sponsors.
Is that a crime? Russian courts mainly say no.

Kind regards,
Mittyri

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