RUSSIAN CLINICAL TRIAL MARKET: 2011 IN REVIEW
2011 has been a turbid year for the Russian clinical trial market. The Russian Federal Law on Circulation of Medicines which came into force on September 1st 2010 introduced special requirements to registration of new drugs on the Russian market, with the most relevant part being a requirement for a local registration study of the drug being registered.
When this law entered into effect, a significant amount of uncertainty ensued. Foreign pharmaceutical companies could not get a clear answer as to whether the whole registration trial had to be conducted in Russia; only part of it and if such, how large of a part?
It appeared that serious restructuring within the Ministry of Healthcare and Social Development had lead to a confusion and ineffectiveness within its ranks. No clear answers could be given by the government, which has caused a significant cooling on the part of Western Pharma, even its sector that was customarily interested in registering their NDEs in the growing Russian market.
Aforementioned situation had a negative impact on the number of clinical trial approvals in Russia in the beginning of 2011 but in overall number of approvals of international multicenter trials in 2011 was even higher than in 2010, what is a very positive trend in this year. Below please find a table that shows comparative analysis of clinical trial approvals in 2011 as compared to the same period in 2010 (data presented by Association of Clinical Trials Organizations).