Pharmaceutical market in Russia is rapidly growing. Annually its volume increases by about 14-15%. On the world stage, Russia ranks 11th in average use of medicines.

Companies providing services in the area of pharma regulatory affairs in Russia, work with such authoritative bodies as the Government of the Russian Federation and Clinical Pharmacology Service.

In their turn, these regulators have a complex organization structure. They are divided into the following elements:

  • The Ministry of health and social development of the Russian Federation,

  • Commission on clinical pharmacology expert Council,

  • Research institutes,

  • Laboratories of pharmacology, etc.

The main functions of these regulatory bodies are: training doctors in the area of drugs appropriate use, expertise of ongoing pharmacological therapy, participation in development and introduction of the formulary system, participation in clinical trials, study on the use of medicines in relation to the medical institution profile, coordination of purchased medicines for coherence with healthcare standards and patients consulting.

Companies providing services in the area of regulatory affairs will help pharmaceutical companies to bring their products to the markets of Russia and Eastern Europe.

Pharmacovigilanceis a system for collection of data required in the implementation of monitoring of drugs and monitoring of adverse reactions in patients, as well as to implement scientific evaluation of the data. It arose as a consequence of the decision on the establishment of companies that provide services for the safety of medicines and analyzing launch of a pharmaceutical product.

Two key areas that can be highlighted in pharmacovigilance are assessment of medication reliability at the stage of clinical trials and drug safety monitoring in the current market. During clinical test drugs are tested on a limited number of people in the selected period of time. After the drug is launched to the market, professionals need information about the use of this product by certain groups of population. Information about systematic consumption, drug safety and effectiveness, mainly in combination with other drugs will be also very significant. With regard to the national pharmacovigilance requirements the basic documents under the name of “Rules of good practicein Pharmacovigilance” regulate activities of pharmacological companies. Drug producing companies that sell drugs in the market, should also provide information to the national health authorities of all the expected and not anticipated reactions to the drug.

Committee on risk assessment in the field of pharmacovigilanceis in charge of smooth functioning of the system, as well as of monitoring possible medication danger . Ensuring effective operation and control of systems within drug manufacturers’ own countries is one more specific function of pharmacovigilance in Russia. The list of the maiorpoints of the above rules containes: pharmacovigilance system and quality criteria and their functioning; various inspections and tests: risk assessments, manufacturing site inspections; public participation in pharmacovigilance; international cooperation, etc. Careful monitoring of adverse reactions, gives gives drug producing companies real opportunity,to timely introduce relevant changes in the instructions for use of the drug. Extensive analysis allows doctors and patients to receive full and objective information about drug safety.

Pharma regulatory affairs in Russia

In Russian Federation Initial State registration of a pharmaceutical product requires presenting a statement of conformity of the manufacturer to the Russian GMP standards that should be issued by the Russian authority.  This initial state registration is valid for 5 years and as of January 1, 2016  it is to be confirmed by the Russian Federation Ministry of Health (MOH).

The ministry is to issue an unlimited marketing authorization upon the request of its initial holder. However, it is not always possible to make timely registration of the new medicinal products due to practical and administrative difficulties of carrying out the inspection for such conformity for pharmaceutical facilities that are located outside of Russia.