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Development of a go-to-market strategy for medicines
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:
- all medicinal products subject to first launch into circulation in the Russian Federation;
- medicinal products registered earlier, but produced in other dosage forms in accordance with the list of dosage forms names, in a new dosage with its clinical significance and effectiveness proven;
- new combinations of previously registered drugs.
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:
- If the drug applied for marketing authorization is generic, and its reference drug is authorized and used in Russia for more than 20 years.
- If international multicenter studies with Russia participation have been conducted.
- If a drug with composition identical to the reference drug is an aqueous solution for parenteral (subcutaneous, intramuscular, intravenous, intraocular, intracavitary, intraarticular, intracoronary) administration.
- If a drug with composition identical to the reference drug is a solution for oral administration.
- If a drug has composition identical to the reference preparation, and is produced in the form of a powder or lyophilizate for solution.
- Medical gases.
- If a drug with composition identical to the reference drug is an ear or eye drug produced in aqueous solution form.
- If a drug with composition identical to the reference drug is an aqueous solution for topical application.
- If a drug with composition identical to the reference drug is an aqueous solution for use in the form of inhalations with a nebulizer or as a nasal spray applied with similar devices.
Mandatory documents that must be attached to the dossier in order not to receive a primary refusal of authorization are:
- statement of production compliance with the rules of good manufacturing practice (GMP certificate) issued by the Ministry of Industry and Trade of the Russian Federation;
- report on the clinical trial conducted in the Russian Federation (if a clinical trial performed in Russia is required for this drug);
- complete registration dossier;
- samples of one drug batch to be submitted for quality control (certificate of analysis for this batch should be presented in a dossier).
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.