Bioequivalence and Bioavailability Forum • WHO FDC Scenario 2

WHO FDC Scenario 2 [Design Issues]

posted by mittyri – Russia, 2019-11-19 10:25 (1618 d 02:06 ago) – Posting: # 20826
Views: 5,094

Hi PharmCat,

❝ Sorry, but no. Ask how FDC registration performs in EU or FDA.

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.

❝ Russian regulatory doesn't have guidance about FDC, but it coming as EEU document.

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

❝ We don't know nothing about new FDC - no safety, no efficacy data. This is new drug.

Yes, that's a new drug, but please look at the Scenario 2 from the link you provided
Scenario 2 The new FDC-FPP contains the same actives in the
same doses as an established regime of single entity products, and
the dosage regimen is the same. Alternatively the established
regime may involve combinations of single entities and FDCs, for
example, a single entity FPP combined with an FDC-FPP that
contains two actives. In all cases, the established regime has a
well-characterized safety and efficacy profile, and all of the FPPs
used in obtaining clinical evidence have been shown to be of good
quality.

The requirements for Scenario 2 are very similar to Scenario 1

❝ existing examples do not confirm the fact - is it legal or not.

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

—
Kind regards,
Mittyri

Complete thread:

Reference drugs for triple combination test drug in Russia Beholder 2019-11-13 12:47 [Design Issues]
- Reference drugs for triple combination test drug in Russia PharmCat 2019-11-13 21:25
  - Reference drugs for triple combination test drug in Russia Yura 2019-11-14 09:24
    - Reference drugs for triple combination test drug in Russia Beholder 2019-11-14 10:55
  - Reference drugs for triple combination test drug in Russia Beholder 2019-11-14 10:51
    - Reference drugs for triple combination test drug in Russia Mikalai 2019-11-15 13:36
      - OT: Speak with the regulator Helmut 2019-11-15 13:45
    - Reference drugs for triple combination test drug in Russia PharmCat 2019-11-15 20:07
      - Reference drugs for triple combination test drug in Russia mittyri 2019-11-15 23:29
        
        Reference drugs for triple combination test drug in Russia PharmCat 2019-11-16 17:22
      - Reference drugs for triple combination test drug in Russia Beholder 2019-11-18 10:13
        
        Reference drugs for triple combination test drug in Russia PharmCat 2019-11-18 22:47
        
        WHO FDC Scenario 2mittyri 2019-11-19 09:25
        
        WHO FDC Scenario 2 PharmCat 2019-11-19 23:42
        
        EEU FDC Scenario 5.3.2 mittyri 2019-11-20 11:32
        
        EEU FDC Scenario 5.3.2 PharmCat 2019-11-20 15:39
        
        EMA example mittyri 2019-11-21 12:38
        
        Reference drugs for triple combination test drug in Russia Beholder 2019-11-19 14:39
        
        Reference drugs for triple combination test drug in Russia Yura 2019-11-19 21:51
        
        Reference drugs for triple combination test drug in Russia PharmCat 2019-11-21 14:02