To launch a medicinal product to the pharmaceutical market of the Russian Federation, it is mandatory to register it by obtaining a marketing authorization. Proper consideration of all stages preceding the registration of a medicinal product helps to cope with this task in the shortest time possible.
Registration is a state expert review of quality and an assessment of the ratio of the expected benefit to the potential risk of product use for the purpose of the subsequent permission of human use of the drug. These functions in Russia are entrusted to the Ministry of Health of the Russian Federation.
In accordance with the Federal Law dd. 12.04.2010, No. 61-FZ "On Medicine Circulation", obtaining of marketing authorization is compulsory for:
The procedure for marketing authorization of foreign and Russian drugs is identical. The process of a medicinal product marketing authorization consists of two main consecutive stages: pre-authorization procedures and authorization of a medicinal product.
At the pre-authorization stage, the manufacturer is evaluated for compliance with regulatory requirements (GMP standard); organization of product clinical trials and preparation of a registration dossier take place. However, in accordance with the Federal Law No. 61, Article 18, paragraph 10, not all of medicinal products require clinical trials:
Mandatory documents that must be attached to the dossier in order not to receive a primary refusal of authorization are:
Each of pre-registration preparation stages necessary in your case can be organized by our company with further provision of the results of the work. These preclinical and clinical trials can be used not only in the preparation of the registration dossier, but also in developing a strategy for introducing the drug in the activities of your company's marketing department.
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