In response to inquiries from the media about the introduction of pharmaceutical drugs to civil circulation, Roszdravnadzor has the following to inform

In response to inquiries coming in from the media and the professional pharmaceutical community regarding the bill “On the Introduction of Amendments to Individual Laws of the Russian Federation Concerning the Introduction of Pharmaceutical Drugs for Medical Purposes to Civil Circulation,” the Federal Service for Supervision of Health Care (Roszdravnadzor) has the following to inform.

The population of the Russian Federation must be provided with quality and safe pharmaceutical drugs.

At the present time, the introduction of pharmaceutical drugs to civil circulation is carried out by means of mandatory conformance confirmation in the form of declaring or mandatory certification, which contradicts the law of the Eurasian Economic Union (EEU) on technical regulations because pharmaceutical drugs are not included in the EEU Unified List of Products subject to mandatory conformance confirmation (Decision No 620 of the Customs Union Commission, dated 7 April 2011).

The bill “On the Introduction of Amendments to Individual Laws of the Russian Federation Concerning the Introduction of Pharmaceutical Drugs for Medical Purposes to Civil Circulation” (“the Bill”) was developed with the aim of amending the Russian Federation law to conform to the EEU law and in pursuance of the direct order of President Vladimir Putin of the Russian Federation to create an effective mechanism for control of the introduction of pharmaceutical drugs to civil circulation.

The bill was drafted to allow for observing patients’ rights to quality medical assistance and for ensuring a balance between the safety of pharmaceutical drugs for the population of the Russian Federation and the interests of the owners of pharmaceutical drugs. On the whole, as provided for in the bill, the switch from the conformance confirmation system to the system of informing a government agency will remove the financial and administrative barriers to introducing pharmaceutical drugs to civil circulation (cancelling the need to follow the conformance confirmation procedure series by series and to pay for this procedure). Responsibility for the quality of pharmaceutical drugs introduced to civil circulation will rest with manufacturers of pharmaceutical drugs and with organisations importing pharmaceutical drugs into the country, as owners of such products and representatives of manufacturers, as per the Russian Federation law.

An additional measure of control will consist in quality assurance of three series of pharmaceutical drugs imported or manufactured for the first time, such quality assurance to be carried out at government laboratories, to guarantee conformance of the conditions under which the new drug is manufactured on an industrial scale at a specific industrial facility (with confirmation in the system of labelling pharmaceutical drugs – starting from 1 January 2019). This measure was already used as a measure of government control before 2010 and showed its effectiveness by way of quality assurance for new pharmaceutical drugs.

The cost of quality assurance for samples of three series of a pharmaceutical drug cannot be a considerable financial burden on the manufacturer compared with present-day expenditure to confirm conformance or with financial losses incurred when a rejected series of a pharmaceutical drug is removed from circulation.

It is also necessary to note that deployment of the automated system for monitoring of the movement of pharmaceutical drugs being currently implemented as part of the priority project “Medicines: Quality & Safety” and implementation of the new system for introducing pharmaceutical drugs to civil circulation will make it possible in a unified information system to monitor the movement of drugs from a specific industrial facility (either in Russia or abroad) to the end user and control their quality at every link of the supply chain; and will be an effective measure for protecting the population from counterfeit pharmaceutical drugs and for promptly removing counterfeit or inferior-quality medicines from circulation.

The bill also provides for government regulation of the introduction of immunobiological drugs to civil circulation by means of an appropriate approval granted by a federal executive agency exercising control and supervision of health care.

Immunobiological drugs (vaccines, toxoids, toxins, sera, antibodies, and allergens) are used for immunoprophylaxis and ensuring epidemiological and biological safety of the population of the Russian Federation, which suggests their use by many people (mostly children). In this connection, quality assurance of such drugs demands a special approach from the state to guarantee safety of their use.

The draft federal law takes account of and implements international best practice and recommendations of the World Health Organization. Introducing these approaches will, among other things, improve the export potential of the Russian Federation.