Current issue #5, 2016

State Institute of Drugs and Good Practices (GILSNP) starts inspections of foreign manufacturers’ sites

Since February 15, the State Institute of Drugs and Good Practices is entitled to inspect foreign manufacturers’ sites for GMP compliance pursuant to the Ministry of Industry and Trade order that approved the fee calculation methods for such services. Foreign pharmaceutical manufacturers are surprised by the fact that the applicable documents were approved in such a short time whereas their absence prevented them from undergoing the inspection procedure from January 1, 2016. The documents that were to be approved not earlier than March are dated January 11 and have a note of registration at the Ministry of Justice dated February 2. Experts note that such approach to inspection on the regulators’ part has become a trend.

[PharmVestnik # 5, 16/02/2016, p. 1, cont’d p. 4]

A percentage of Russian cancer drugs to reach 35% within the next three years

On per capita basis, the Russian cancer treatment facilities receive 9 times less funding than those in the developed European countries and the USA. Such data was voiced on February 4 within the framework of the 9^th Forum “Movement against Cancer”. The financial problem may be partly resolved, in particular, due to import substitution. The medical community insists on maximum possible and at the same time rational drug substitution. According to analysts, the cost of local drugs will be 20% lower at maximum vs. imported medications.

[PharmVestnik # 5, 16/02/2016, p. 2]

Roszdravnadzor doubts the information on cancer drug disappearance from the market

The story regarding daunorubicin the production of which, according to charitable foundations, has been allegedly terminated and, according to relevant agencies, has, on the contrary, increased is approaching its logical end. The state agencies and the manufacturer officially declared that the drug that was allegedly absent from Yekaterinburg children’s cancer center for nearly a month is available for purchasing. However, this temporary interruption of supply of daunorubicin, which is a vital drug, has for another time highlighte...