Snapshot

The Accelerated Procedure for Expert Examination of Medicines pathway has been developed by the Ministry of Health of the Russian Federation of Russia.

Accelerated procedure for expert examination of medicines shall be performed under decision of the relevant authorized federal executive body within the period not exceeding sixty business days. In this case expert examination of the documents contained in the registration dossier for the purpose of obtaining a permit to conduct a clinical trial of a medicinal product for medical use and ethical expert examination shall be performed within the period not exceeding fifteen business days, and expert examination of the quality of a medicine and expert examination of a correlation between the anticipated benefit and possible risk from the use of a medicinal product shall be performed within the period not exceeding five business days.