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The Ministry of Healthcare of the Russian Federation has approved a scope of documents and data required to form part of clinical documentation for marketing authorization of an orphan drug.

The clinical documentation section should provide reports on results of clinical trials performed in the Russian Federation and reports of international multicenter clinical trials of the orphan drug, part of them performed in the territory of the Russian Federation.

The following reports are required:

— results of studies of bioavailability, studies establishing correlation of results obtained in vitro and in vivo;

— results of pharmacokinetic studies;

— results of Pharmacodynamic studies;

— results of clinical trials of efficacy and safety.

If it is impossible to provide reports on results of clinical trials of drugs performed in Russia and reports on international multicenter clinical trials, partly performed in Russia, reports on foreign clinical trials performed according to Good Clinical Practice may be submitted.

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