Leading global drugmakers operating in the Russian market have called on the country’s government to ease the current conditions for conducting clinical trials of their drugs in Russia, according to recent statements from the press-service of the Russian Ministry of Health.
According to producers, for the last five years the number of rejections for approval to conduct clinical trials of their drugs in Russia has increased by more than five times, while their number continues to grow, reports The Pharma Letter’s local correspondent.
The main reasons for the rejections are insufficient data on investigational drugs provided by producers, despite the fact that the same data fully satisfied regulators from the USA, Japan and the European Union. The situation is aggravated by the regular delays in the issuance of permissions.
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