Successful registration for OTC, drugs, medical devices and Food Supplements in Russia

Growing market

Russia is the largest country in the world geographically and is among the top ten countries with the highest population, accounting for more than 146 million people. Many OTC and Rx segments in the healthcare segment still demand for new market entries, especially with regards to imported high quality products. Therefore Russia has a big potential for pharmaceutical companies.

The number of drug packages sold during 2017 through the pharmacy network accounted for 5,066 million units, which is worth 941 billion rubles (approximately 12 billion euros). This represents an increase of 6.5% in terms of value and 3.5% in physical terms in comparison to 2016.

It is expected that the Russian pharma market will continue to grow and to be attractive for investors because:

  • Its development is 5-6 times above the EU level
  • More than 70% of the Pharma/OTC products in the market is still imported.

Registration for OTC, drugs, medical devices and Food Supplements is complex

In recent years Russia has been stricter regarding the registration of goods used in the medical and health sector.

The new Law on Circulation of Drugs stipulates the requirements and procedures any pharma product has to go through in order to be registered for the purpose of production and/or commercialization on Russian territory. Under this law, every product has to be registered with the Ministry of Health and GMP audits became a must.

The process for registration is complex and consists of different sequential stages.

Stages

Stage 1: Execution of pre-clinical trials.

Stage 2: Obtaining permission to conduct a clinical study in the Russian Federation with clinical trials.

Stage 3: Creation of a registration dossier; including necessary documents for clinical study initiation and submission of the Registration Dossier to the Ministry of Health.

Stage 4: Drug quality control at the FSBI SCEMP´s laboratory and approval of a normative document (specification and analytical procedures); and evaluation of the expected benefit and possible risk ratio and approval of the instruction for medical use of a drug.

Stage 5: Decision by the Ministry of Health of the Russian Federation about the registration of the pharmaceutical product, and it´s entrance in in the State Register of pharmaceutical products and marketing authorization issuance.

Our experience and USP with registration in Russia

Our experts have more than 20 years of regulatory experience in Russia. This wide network of experts that includes regulatory officials and former MoH experts, allows us to successfully solve even the most difficult and complicated cases.

CPC is able to conduct pre-expertise reports (a kind of gap-analysis of the dossier) with the experts in the Federal State Budgetary Institution “Scientific Center for Evolution of Medicinal Products” (FSBI SCEMP). This helps us understand and follow the best regulatory strategy, reduce costs and finalize the registration in a shorter period of time.

CPC provides regular update calls to clients, allowing them to ask questions and inquiries and to understand the status of the procedure.