Current issue #36, 2015

Labeled packaging

A document on implementing drug labeling under development

In late October, the Federal Service for Surveillance in Healthcare and Social Development (Roszdavnadzor) informed the professional community about the development of the concept of a Federal state information system for monitoring drug flow from manufacturer to customer using labeling. Probably because this document is unfinished yet, the agency did not find it expedient to familiarize market players with its text, but promised to present it for public discussion in near future. Meantime, some experts have managed not only to review the concept developed under the auspices of the MoH but also make a conclusion on who was the real author of this draft document. It also became known to PharmVestnik that in the end of September, First Deputy Prime Minister Igor Shuvalov took care of the drug labeling issue. He issued an order to explore the issue for the Ministry of Economic Development, Ministry of Industry and Trade, and Ministry of Agriculture. PharmVestnik has failed to receive any explanation from Roszdavnadzor on whether the agency’s activities were related to Mr. Shuvalov’s initiatives.

[PharmVestnik # 36, 10/11/2015, p. 1, cont’d p. 2]

On “inoculating” localization

Natsimbio is skeptical about some foreign technology transfer projects

The National Immunobiological Company (Natsimbio) that from the very moment of emergence has been the center of talks about the state monopoly in the vaccine market continues introducing Pharma companies to the new game rules. The unitary vaccine supplier was very tough and unambiguous when stating its strategy, namely: the companies willing to continue operating in the Russian market must resolve the issue of launching a full-cycle manufacturing of their own in Russia’s territory. In late October, Natsimbio held more than 20 meetings and negotiations with pharmaceutical manufacturers on this topic. Until specific agreements are signed, the company intends to withhold from disclosing the names of the markets players who have made their way to Natsimbio’s pool. However, it is known that the focus was on API manufacturers.

[PharmVestnik # 36, 10/11/2015, p. 3]

Health technology assessment system to be formed under MoH

The development of a new system, i.e. health technology assessment (HTA), is underway in Russia. At stage 1, it will provide for assessment of drugs being included into various lists as...