Current issue #19, 2016

Russia’s President signed a list of orders to regulate drug market

The State Drug Register faces a dramatic revision. All generics without evidence of safety and therapeutic efficacy are to be removed from it. This is required pursuant to the list of orders signed by President Putin on April 30. This document is confidential; as of May 30, the relevant agencies were unaware of it yet. The professional community was apprehensive about this document. Some experts even concluded that part of the wording used in this document might trigger a market collapse.

[PharmVestnik # 19, 07/06/2016, p. 1, cont’d 5]

A bottleneck

Starting from January 1, 2017, any foreign pharmaceutical manufacturer will be required to have a GMP certificate

A Russian GMP compliance certificate became the focus of special attention a few months ago. Notwithstanding the fact that all regulatory gaps have been bridged there are two opposite viewpoints at the Russian GMP Inspectorate in terms of the current regulation: the regulators do not see any problems and behave reassuringly, while the foreign manufacturers led by the AIPM are worried. PharmVestnik decided to make out who and when might need a Russian GMP compliance certificate.

[PharmVestnik # 19, 07/06/2016, p. 2]

FFOMS accuses Kirov region of trickery

According to experts, the results of the only pilot drug reimbursement project pursued by Kirov region are doubtful. The reimbursement project for cardiovascular disease patients launched in 2013 has demonstrated fantastic results: its economic effect at 90.5 mn RUB exceeded threefold the regional budgetary allocations for the program implementation. The only “but” is that the region cannot make use of this money as the money is “caught” somewhere in the healthcare system. In turn, analysts and the Federal Mandatory Medical Insurance Fund (FFOMS) assert that there are no millions of rubles freely available and that the Kirov regional government obviously magnify their pilot project’s efficiency.

[PharmVestnik # 19, 07/06/2016, p. 3]

Why Pharm-Sintez developed Copaxone and Velcade generics but failed to market them

In early May, R-Pharm announced that they registered the first in Russia Copaxone (glatiramer acetate) generic. However, another Russian manuf...