New opportunities for the medical industry

The head of Roszdravnadzor Mikhail Murashko has taken  part in the conference “Defense industry of Russia – new opportunities for the medical industry”

The head  of Roszdravnadzor Mikhail Murashko took part in the conference “Defense industry of Russia – new opportunities for the medical industry”, which took place July 1, 2016 in Tula.

During the plenary session Mikhail Murashko gave a presentation devoted to the issues of availability and quality of medical products in the Russian Federation.

Currently Roszdravnadzor has created the necessary technical capacity to conduct trials of medicinal products and the quality of medical devices.

So, in all federal districts open the modern laboratory complexes capable to conduct quality tests of medicinal resources of any complexity approved pharmacopoeial methods (all the facilities are provided by mobile laboratories).

The state control system implemented non-destructive package express methods for determining the authenticity of medicines (NIR spectroscopy and Raman spectroscopy).

Laboratory facilities are accredited for compliance with Russian and international standards. An agreement was reached on the accession of the laboratory complex in Krasnoyarsk network Official medical laboratories EDQM (GEON).

The quality of medical products is checked at All-Russian Research and Testing Institute Roszdravnadzor medical technology, the most important tasks are the improvement of expertise and test components of state control in the field of medical devices and the provision of Russian health care quality, high efficiency and safety of medical devices. For this purpose the  institute is equipped with 10 modern laboratories and high-class experts.

“The Russian manufacturers have learned to produce competitive products that we note the high quality products for ivitro and X-ray diagnostic equipment, – said the head of Roszdravnadzor. – But it’s early to be satisfied with what has already been achieved: our producers should be esportoorientirovannymi since entering the international level will be a good impetus for the development of the Russian health care products market in general. “

Speaking about the strategic objectives and priorities for the development of domestic production of medical products, the head Roszdravnadzor identified several main directions: production of high-quality medical products, not under patent protection, at a lower price and other competitive advantages; ensuring independence of the state for the production of medical immunobiological drugs (including vaccines), medicinal products from the list of VED, implantable medical devices, blood substitutes and blood factors, diagnostic and therapeutic medical equipment; the development of scientific research and production in the directions of increase of efficiency of therapy of socially significant diseases; development of telemedicine systems and innovative technologies.

At the same time, the head of the Service, added that special attention should be given to the introduction of common standards and requirements, including the harmonization of international law.

Roszdravnadzor, for its part, has conducted some educational activities:the training seminars for medical product manufacturers  are delivered on a regular basis (in particular, a seminar on the pre-qualified by WHO requirements for medical devices for invitro diagnostics  with representatives of the World Health Organization was held in June 2016). Also, the Federal Service for Supervision in the sphere of public health is working closely with MIPT and Bauman Moscow State Technical University, on the basis of which the training courses and seminars are held.

For the purpose of decrease in administrative load of respectable producers of medical products by Roszdravnadzor actions risk – the oriented approach are realized, lists of under control subjects on risk groups (I-IV) of potential damnification to health and life of citizens are prepared, frequency rate of carrying out behind them control actions is determined.

In the conclusion of the report Mikhail Murashko has told about the major legislative changes in the sphere of the address of medical products and has urged producers to support the registration file on products in an actual condition, to timely eliminate the violations revealed by the regulator and to provide reliable information in regulatory body.

In order to reduce the administrative burden on law-abiding manufacturers of medical products Roszdravnadzor implemented measures the risk-oriented approach, prepared lists of entities controlled by risk groups (I-IV) the potential harm to the health and lives of citizens, defined multiplicity of them control measures.

In conclusion of his report, Mikhail Murashko described the most important legislative changes in the sphere  of medicinal products and urged producers to maintain the registration dossier for the products up to date in a timely manner to eliminate the revealed violations of the regulator and provide accurate information to the regulator.

Reference of Roszdravnadzor:

According to open sources, the volume of the Russian pharmaceutical market in 2015 amounted to 1 064 billion. rub. (5084 million packages.), including the domestic segment of the 286 billion rubles( 3084 mn units), foreign – 778 billion rubles.. (2 000 million. packages).

Today, there are records of more than 13 thousand of the registration certificate of medical devices in the State Register of medical products (2 323 INN), including for domestic – 8440, import – 5188.

The amount  of the Russian market of medical products in 2015 amounted to 269.4 billion. rubles. The production growth (compared with 2014 year) medical devices in the 9.08% in 2015 (39.1 billion. Rub.), As well as growth in exports of medical devices produced in the Russian Federation by 13,7% (3, 2 billion rubles.) were noted.

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