Seventy percent of new drugs registered in Europe in 2015 were tested in phase II-III clinical trials in Russia, according to Smooth Drug Development, the first local company implementing ISO 9001:2008, a global standard for quality management in the country.
“Since the US FDA accepts foreign data as long as it is relevant to the medical practice in the US, Russia is known as a place of choice for placing large international clinical trials,” according to Julia Sardaryan, Corporate Development Director at Smooth Drug Development.
In 2014, the FDA’s Center for Drug Evaluation and Research (CDER) approved more than 111 new drugs, 45 of which were also studied in Russia. According to Sardaryan, there are several reasons for this; one of which is simply the country’s population of more than 146 million people.
This number lends itself to high recruitment rates of drug-naïve patients. Access to these patients, who, according to Sardaryan, are eager to participate in clinical trials in order to get access to new therapies, also makes enrollment periods much shorter in Russian than in the US and Europe. Additionally, there is also no shortage of motivated investigators, for which there is little competition.
Cost savings connected with currency exchange rate, a centralized healthcare system, which enables initiation of fewer sites, and a developing infrastructure are also among the advantages Russia offers in early phase studies, according to Sardaryan.
Regulatory environment
“Since 2010 the Russian legislation requires clinical data produced from local population for drug registration, so local patients in multinational studies enable an improved and faster regulatory access to the Russian market,” said Sardaryan.
Several other processes and timelines have been established for regulatory approval, which takes 35 working days. “[This] is absolutely comparable with European timelines for clinical trials. The documents are submitted in the local language,” se continued, adding that “No IMPD is required.”
The Russian government is taking steps to improve the regulatory environment surrounding clinical trials Sardaryan said. For example, in 2014 the country approved amendments to Federal Law 61 “On Circulation of Medicines.”
“In addition to important changes in term definitions … the law will allow companies to obtain official scientific advice on issues relating to pre-clinical studies and clinical trials,” Sardaryan said
Moving forward, Russia has created the Pharma 2020 initiative, a state policy with the goal to develop conditions “for the transition of the Russian pharmaceutical production towards an innovative development model,” she added.
As part of the initiative, the government has allocated financial resources, including federal budget, commercial, and non-governmental organization funds, as well as other non-budgetary funds.