Drug Registration in Russia from Russian CRO #1


OCT provides our foreign and local clients with a full spectrum of services connected with state registration of drug products in Russia. Our support includes:

  • Dossier document collection and writing in accordance with Russian legislation requirements
  • Preparation of all components of the registration dossier: administrative, pharmaceutical, technological, pre-clinical and clinical
  • Submission of the registration dossier to the Ministry of Healthcare of the Russian Federation
  • Qualified support and cooperation with state authorities during all steps and all kinds of registration procedures, processing of official requests and notes
  • Obtaining Drug Registration Certificate and provision to the client.

The process and timelines of drug registration in Russia can be described as follows:

  • 1
    STEP ONE:

    Approval for Clinical Trial obtained.
    Clinical trial conducted
    Clinical trial's duration

  • 2
    STEP TWO:

    Registration Dossier collection
    2.5-3 months

  • 3
    STEP TREE:

    Submission of the dossier with the results of clinical studies in the Ministry of Health, the examination of the registration dossier for the drug.
    5.5 months

  • 4
    STEP FOUR:

    Decision of the inclusion of the drug into the State Register of Medicine made. Drug Product Registration Certificate issued.
    3 months