Mikhail Murashko, Head of Federal Service for Surveillance in Healthcare, took part in a breakfast briefing held at Russian Federal Chamber of Commerce and Industry. He told about the routine of pharmaceutical industry in the light of new regulations adopted by EAEC, that entails significant changes.
Transfer to a risk-based approach will be an important process in terms of regulation, control and surveillance. Four risk-groups were identified for all subjects involved in the turnover of healthcare products and in rendering of medical care services.
Since 2015 Roszdravnadzor has been elaborating a so-called check-lists system; it is already being implemented in some regions and helps to evaluate the organization of medical care within the health care facility. Similar check-lists are being developed for manufacturers of medicinal produce. Mikhail Murashko has emphasized, that it will lead to transparency, efficiency and stronger competition.
The goal of improving the control and surveillance system is to receive information about the subjects working in the sector without interfering too much in their operations with control and supervisory measures, but instead evaluating industry parameters remotely. One of the monitoring directions is the introduction of labeling that allows controlling prices; it is also promising in the fight against counterfeiting.
Mikhail Murashko has mentioned that it is important to maintain export potential of the industry. The products that have been approved in Russia (medicinal drugs and equipment) should be recognized in the world. Also he said that CCI RF puts much effort to enable Russian products to actively enter the foreign markets.