Business breakfast at the Chamber of Commerce (with Roszdravnadzor head)

The head of Roszdravnadzor Mikhail Murashko answered questions from the leaders of pharmaceutical companies during a business breakfast at the Chamber of Commerce of the Russian Federation.

On February 22, 2017, the head of Roszdravnadzor took part in a business breakfast organized by the Chamber of Commerce of the Russian Federation as part of the “Meetings on Ilyinka” function. During the event, Mikhail Murashko told the representatives of pharmaceutical companies about the Agency’s core lines of activity, plans for 2017, legislative initiatives and answered questions that are of interest to businesses.

27Declaring the meeting opened, the RF CCI President Sergey Katyrin noted that the main task of the Chamber of Commerce of the Russian Federation is establishing ties between business and the government and an expert assessment of legislative initiatives. He added, “Today’s first industry meeting devoted to developing the pharmaceutical and medical sectors is more relevant than ever with the rapidly changing legislation.”

The head of Roszdravnadzor confirmed that 2017 is the year of drastic changes and he announced major initiatives.

Transition to the risk-oriented model in regulatory activities.

Roszdravnadzor is a member of the priority project to implement a risk-oriented model in regulatory activities governing the following areas in state control: state control of the quality and safety of medical activities; state supervision in the sphere of drug circulation; state control over the circulation of medical devices as well as associated types of licensed control.

As of today, a passport for the priority project has been developed defining its key goals:

– reduction in the number of fatalities in controlled activities in the healthcare sector by 2% from the 2015 level by 2019 and by 1% annually versus the previous year rate;

– reduction in administrative and financial costs incurred by citizens and organizations engaged in entrepreneurial and other activities associated with Roszdravnadzor regulatory activities no less than by 10% from 2015 level by 2018 and by 3% annually versus the previous year rate;

– growth of the regulatory function administration quality index.

During the transition stage where Roszdravnadzor is switching to the risk-oriented model for regulatory activities, the assignment of control (supervision) objects to four risk categories (hazard classes) is done based on static criteria. In the future, the ranking of control (supervision) objects will be carried out considering both static and dynamic criteria.

“It should be noted that during the introduction of the risk-oriented model, one of the key elements is the openness and transparency for all regulated entities, – said Mikhail Murashko. – In general, by the end of 2017, we expect positive results of the risk-oriented model being introduced by reducing the load on bona fide market players and improving the efficiency of Roszdravnadzor’s control and supervisory activities “.

Roszdravnadzor’s consultations as regards to the procedure for registering medical devices and making amendments to registration dossier.

Regulation of the Government of the Russian Federation dated 10.02.2017 No. 160 “On Amendments to the Decree of the Government of the Russian Federation dated December 27, 2012 No. 1416” provides a possibility for expert institutions reporting to the Roszdravnadzor to give advice on procedures related to the state registration of medical products. Currently, the procedure for such consultations is being finalized.

A possibility to use a notification form when making amendments to the registration dossier or registration certificate not leading to the change of properties, characteristics, effectiveness and safety of a medical product.

Currently, there is no such a possibility in the legislation of the Russian Federation on the registration of medical devices.

However, this possibility is being discussed within the single market of medical products in the Eurasian Economic Union (EAEU). The draft Requirements for the implementation, maintenance and evaluation of the quality management system of medical devices depending on potential risks of their application, which is currently being discussed by EAEU member States and the Eurasian Economic Commission, provides that in case of the introduction and maintenance by manufacturers of medical devices of classes of potential risk of 1 and 2A (non-sterile) for quality management systems including the development and designing processes, the changes to the registration dossier for such medical devices will be made in the form of a notification. This approach is consistent with the recommendations of the International Medical Devices Regulators Forum (IMDRF) and the international medical devices regulatory practice.

Pilot Drug Labeling Project

The experiment is conducted voluntarily based on applications of subjects of drug circulation in the period from 1 February to 31 December 2017.

The Government Regulation provides that the drug manufacturers perform the drug labeling with control (identification) signs for the purposes of the experiment using two-dimensional bar code. The drug manufacturer chooses the labeling method.

The said labeling application does not require making amendments to the drug registration dossier.

Fifty drug types, twenty-six producers, four distributors, three pharmacy chains (about 250 chemist’s shops) and thirty-two medical organizations have been declared to participate in the experiment. At the initial stage, the experiment will cover six regions, and then will be extended to other regions.

Currently, the draft guidelines establishing the encoding rules, requirements to the information system and equipment, the information transfer and exchange procedure, the procedure for the participant registration in the system and other materials are publicly available on Roszdravnadzor’s website.

“Pharmaceutical companies, which filed applications to participate in the pilot project, express confidence that the labeling system will help them to protect themselves from counterfeit products and re-usage of drugs in retail network, – said Mikhail Murashko. – In addition, their production will become more profitable, as the companies’ management will have an opportunity to develop clear-cut drug production plans using information about the amount of drugs in turnover”.

In addition, the head of Roszdravnadzor answered the questions regarding the availability of innovative drugs, reference pricing for pharmaceuticals, the control mechanism of pharmaceutical substances, the registration of medical kits, which include already registered medical devices.

At the end of the meeting, the RF CCI President Sergey Katyrin thanked Mikhail Murashko for his participation in the business breakfast and expressed hope that the dialogue with the business community will be continued.