Current issue #15, 2017

Federal Tax Service: implementation of drug marking system not to horrify

July 1^st, 2017 will be a milestone for launching the drug marking system. To this date, the appropriate software shall be installed, and the pilot project participants shall get an access to the system. By September 1^st, the system shall be integrated with the departmental systems of the key participants of the marking process, the interim results being reviewed in December. From 2018, all Russian pharma market players will be connected to this system gradually but quickly. The Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor) warns that this process will not be chaotic. The companies will not be given any choice in respect of the system joining date. To avoid crowd behavior closer to the system hookup deadline, Roszdravnadzor decided to develop a separate regulation for connecting to the drug marking system.

[PharmVestnik # 15, 02/05/2017, p. 1, cont’d p.2]

Experts pinpointed major regulatory risk factors in pharma

Speaking about regulating the pharma industry is like trying to seize the unseizable. Yet, major industry events cannot do without discussing the regulatory aspects of the market drivers. The 6^th International Forum “Pharma and Biotech 2017: Pharma business regulation and development in a down economy” was not an exception either.

[PharmVestnik # 15, 02/05/2017, p. 4]

Computerization: major issue of common market launch

Experts of the Eurasian Economic Commission (EAEC) admit that ratification by Kyrgyz Republic of the Protocol of Armenia accession to the EAEU took more time than expected. Nonetheless, the EAEC considers the protocol ratification a fait accompli, although the start of the drug registration to the uniform rules has not been announced yet. There is another difficulty, namely the information support tools for the drug registration processes are not completely in place so far.

[PharmVestnik # 15, 02/05/2017, p. 12]

Local manufacture of orphan drugs is optimum given export prospects

More than ten court proceedings associated with orphan drug coverage were held over the past two weeks in various Russian regions. The problem is common, i.e. the nearly spent regional budgets cannot afford purchasing high-cost drugs. Local manufacturers are ready to produce orphan drugs, which, in their opinion, will be significantly cheaper. However, both patients and physicians have questions in respect of local drugs.

[PharmVestnik # 15, 02/...