WHO FDC Scenario 2 [Design Issues]

posted by PharmCat  – Russia, 2019-11-20 00:42 (1850 d 05:03 ago) – Posting: # 20831
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❝ We all know that Russian practice does not follow EMA or FDA completely ('a very special way'). So we cannot link to that jurisdictions directly.


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

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


Here

❝ Yes, that's a new drug, but please look at the Scenario 2 from the link you provided


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

❝ Do you really think that registered FDC combinations are illegal? :-)


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 But I can't recommend to do this even if a precedent exists (was exists).

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. Some companies take risks and make "force" registration in the hope of managing to get enough profit during this period.

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