Russia: Changed procedure for determining drug interchangeability [BE/BA News]

posted by Beholder  – Russia, 2020-02-21 15:05  – Posting: # 21187
Views: 295

Hi, Helmut!

» do you understand / can you explain what that means?

Firstly: around 5 years ago IB story was started by our government in order to understand whether generics which are present on our market could serve as substitute to reference drug because government buys drugs for Healthcare system. Six points were introduced in order to understand whether drugs are interchangeable:

  1. equivalence of qualitative and quantitative characteristics of pharmaceutical substances
  2. equivalence of dosage form
  3. equivalence of the composition of excipients
  4. the identity of the route of administration and use
  5. the absence of clinically significant differences in the study of bioequivalence (therapeutic equivalence)
  6. manufacturer's compliance with good manufacturing practices

Then companies started submitting the upgrades for their dossiers (together with BEQ reports). The deadline for this was until 31.12.2016. By the 1.1.18 experts were preparing IB register which was introduced within GRLS system. You can see it here at the bottom of the each page for separate drug if you use search. Now some changes are introduced again in IB procedure however as I understood it is not so critical. At least for me.

Secondly: about BEQ. MoH will evaluate BEQ reports also for 20-years-on-the-market drugs which was not performed before, since such drugs were registered without BEQ study. More information here (sorry, only Russian).

Best regards
Beholder

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