Bioequivalence and Bioavailability Forum • Russia: Changed procedure for determining drug interchangeability

Helmut
★★★

Vienna, Austria,
2020-02-21 14:20
(1201 d 07:32 ago)

Posting: # 21186
Views: 2,101

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

Dear all (and esp. our Russian members),

do you understand / can you explain what that means?

Russian President signed Federal Law No. 475-FZ on December 27, 2019, which introduced amendments into several laws, including Federal Law No. 61-FZ "On the Circulation of Medicines" dated 12 April 2010 (Federal Law No. 475-FZ and Law on the Circulation of Medicines). Federal Law No. 475-FZ establishes a new procedure for the medicines' interchangeability. The interchangeability will be determined within the framework of one international non-proprietary name (either chemical or generic name) of the medicine by the Russian Ministry of Healthcare on the basis of an expert commission's report of the relevant expert institution, which will be guided by the criteria established by the Federal Law No. 475-FZ.

In terms of their content, the criteria have not changed. However, some new definitions have been implemented into the Law on the Circulation of Medicines (e.g "therapeutic equivalence of medicines", "bioequivalence of medicines" etc.) for the purposes of administration of the process of determining medicines' interchangeability.

Moreover, the Federal Service for Surveillance in Healthcare (Rosdravnadzor) may order both the holder of marketing authorization for that medicine and the holders of marketing authorizations for interchangeable medicines to make changes into the instruction on use (patient leaflet), if it is necessary based on a pharmacovigilance data.

A new separate registry for interchangeable medicines will be created. The registry will be open and each internet user will have access to it.

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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Beholder
★

Russia,
2020-02-21 16:05
(1201 d 05:47 ago)

@ Helmut
Posting: # 21187
Views: 1,486

Russia: Changed procedure for determining drug interchangeability

Post reply

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:

equivalence of qualitative and quantitative characteristics of pharmaceutical substances
equivalence of dosage form
equivalence of the composition of excipients
the identity of the route of administration and use
the absence of clinically significant differences in the study of bioequivalence (therapeutic equivalence)
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).

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Best regards
Beholder