News
Scientific Center “Vector” applied for registration of the first Russian drug against smallpox
The Scientific Center for Virology and Biotechnology “Vector” has filed an application for registration of the first Russian drug against smallpox. This is reported by the portal – the state register of medicines. The document says that the drug will be produced in capsules.
A Russian drug called НИОХ-14 is reported to be effective against all types of smallpox, including monkeypox virus.
He successfully passed all stages of preclinical trials and the first phase of clinical trials on volunteers.
The advantage of the drug is low toxicity and low effective dose.
Main news for March 1 🇷🇺
The labeling system began tracking the execution of state contracts for the purchase of medicines
The Center for the Development of Advanced Technologies (CRPT, operator of the state labeling system “Honest Sign”) has added to the labeling system the ability to track the execution of state contracts for the purchase of medicines.
Renewal of the license for maintenance (maintenance) of medical devices
The regulator canceled the licensing of the production of medical products and introduced an inspection. But the licensing remains. Companies that carry out maintenance must renew the license before 01.01.2024, even if the renewal took place without an application in 2022.
The experiment on labeling of medical products has been extended for six months
The pilot project on voluntary identification started a year ago, computer tomographs, orthopedic shoes and absorbent underwear fall under it.
Follow all updates in the field of regulation on our “News” tab
MedStandard Rus 🇷🇺
The main news by Friday, March 3
The experiment on labeling of medical products has been extended for six months
The Government of the Russian Federation has officially extended the experiment on labeling medical products for six months, until August 31, 2023. The pilot project on voluntary identification started a year ago, it includes computed tomographs, hearing aids, coronary stents, air disinfectants, orthopedic shoes and absorbent underwear. In December 2022, Deputy Prime Minister – Head of the Ministry of Industry and Trade Denis Manturov announced the extension of the experiment: market participants “identified some features of the turnover of certain types of medical devices,” which requires time to work out the regulatory framework and information system.
Manufacturers of priority products were allocated 1 billion rubles for preferential loans
The government has allocated 1 billion rubles for 2023 for preferential loans to manufacturers of priority products. It also includes the pharmaceutical industry. The corresponding order No. 449-r dated 02/22/2023 is published on the legal information portal. The subsidy is provided within the framework of the state program “Development of industry and increasing its competitiveness”.
Murashko said about overcoming difficulties with the logistics of drug supplies
The head of the Ministry of Health Mikhail Murashko said that there is no shortage of medicines in pharmacies. According to him, all the difficulties with logistics that previously arose have been overcome. In addition, an experiment has now begun on the remote sale of some prescription drugs, the minister stressed.
More news: https://en.medstandard.ru/news/
Happy Womens Day!
The staff of MedStandard Rus sincerely congratulates you on the spring holiday on March 8!
Please accept my most sincere congratulations on a wonderful holiday. Let nature itself, with the first spring sun, give you the energy to realize all your hopes.
Good luck in business, career victories, good friends and a great mood!
MedStandard Strategic Session
On March 7, a strategic session for MedStandard employees was held in Moscow. The meeting discussed the market situation and scenarios for the development of events in the industry, talked about the company’s strategy and in the process of brainstorming managed to solve a number of strategic and operational issues; several ideas were taken into work.
We thank our colleagues from Kazakhstan for providing a vision and strategy for the development of both the company as a whole and the employees themselves.
MedStandard Rus 🇷🇺
Main news by Friday, March 10
New mechanisms to support pharmaceutical manufacturers
The Government of the Russian Federation has until April 1 to submit additional measures of state support for organizations engaged in the development, implementation of CI, production and market launch of medicines. This instruction was given by President Vladimir Putin on March 6. He pointed out the risks of the withdrawal of foreign pharmaceutical companies from the Russian market, the suspension of their CI and, as a result, the emergence of a shortage of medicines.
Prime Minister Mikhail Mishustin has been appointed responsible for the execution of this order.
The human rights organization offered to deliver prescription drugs to beneficiaries for free
The League of Patient Advocates has taken the initiative to expand the experiment on the online sale of prescription drugs. The organization offers to deliver medicines to beneficiaries free of charge, to create a state telemedicine advisory service for the selection of medicines, as well as to write prescriptions in Cyrillic.
Putin instructed to consider additional support for pharmaceutical manufacturers
The Government will consider additional measures of state support for organizations that develop, conduct clinical trials, produce and market medicines. Such an order for a period up to April 1, 2023 was approved the day before by Russian President Vladimir Putin. This is necessary to prevent a shortage of drugs in case foreign pharmaceutical companies leave the Russian market or suspend their clinical trials, according to the Kremlin’s website.
More news: https://en.medstandard.ru/news/
MedStandard Rus
Monday April 3rd
Sanaviation to help deliver medical equipment and medicines
The Ministry of Health of the Russian Federation has developed a draft of an updated model contract for the needs of air ambulance. It will fix the cases in which sanaviation may be involved, indicate the terms of readiness of the vessel, its marking and compliance with the current procedures for providing emergency medical care.
We are talking about the national project “Healthcare”. The new regulation reduces the number of positions of medical equipment from the current 115 to 97 units and, according to the idea of the department, is designed to “ensure continuity” during the implementation of the program to combat cancer.
The government has restricted access to purchases for state needs of a number of foreign-made electronic medical devices. Seven new items have been added to the list.
More news:
https://medstandard.ru/news/
MedStandard Rus 🇷🇺
Main news by Wednesday, March 22
Simplification of conditions for obtaining subsidies
According to the Government decree (https://regulation.gov.ru/projects#npa=136620 ), enterprises from the register of the rehabilitation industry and other companies will receive the right to a subsidy, provided that they provide an obligation to include in the register and revenue from the sale of specialized products in the amount of at least 90% of the total turnover in the current calendar year.
Offset for the supply of medical products for 5 billion rubles
The Moscow Department of Competition Policy has announced a tender for an offset contract for the needs of the city’s blood service. The competition involves a long–term contract for the supply of 1,142 million medical devices – for the transportation and storage of blood – until 2032. In return, the supplier must invest at least 500 million rubles in the localization of products in the metropolitan region.
503 million rubles in healthcare
The Russian government will allocate more than 503 million rubles for scientific research in the field of healthcare under the federal project “Medical Science for humans”.
More news:
https://medstandard.ru/news/
MedStandard Rus
Main news by the evening of Friday, March 24
“The second extra” for public procurement
According to this Resolution, if at least one participant comes to the auction with products from the list produced in the EAEU, all other applications with imported products must be rejected.
Ventilators for 1.2 billion rubles
The Procurement Agency of the Moscow Department of Health (DZM) has announced two tenders for the purchase of a total of 337 artificial lung ventilation (ventilator) devices for intensive care and anesthesiology and intensive care units. The total initial maximum contract prices are estimated at 1.224 billion rubles. Results at the beginning of 2023
The turnover of the shadow market of medical services in 2022 reached 215 billion rubles
Alexander Aronov, Managing Partner of the Moscow Bar Association, noted that, according to the organization’s calculations, the revenues of the shadow market of medical services in Russia in 2022 amounted to about 215 billion rubles, or about 7.5–15% of 3 trillion rubles.
More news:
https://medstandard.ru/news/
MedStandard Rus
Monday 27 March
M&A processes in healthcare will intensify in 2023
Mergers and acquisitions (M&A) activity in the healthcare sector should recover in 2023 after a difficult macroeconomic and political situation, rising inflation, follows from the PWC forecast (https://www.pwc.com/gx/en/services/deals/trends/health-industries.html ). This trend is also noted in the Russian market, the participants of the CEO Summit Medicine noted.
Special mechanisms have been introduced to overcome the shortage of medicines and medical products. There is no global deficit in the country now, the Ministry of Health reported.
500 million rubles for the development of medicines and medical products
The government has allocated over 503 million rubles for the development and creation of products and medicines based on cellular technologies and tissue engineering technologies. The money will be allocated within the framework of the federal project “Medical Science for Man”.
More news: https://medstandard.ru/news/
MedStandard Rus
The main thing is by Wednesday March 29
General approaches to the activities of the sphere of circulation of medical products
The Board of the Eurasian Economic Commission (EEC) has adopted a recommendation regarding the activities of organizations of the states of the Eurasian Economic Union (EAEU) with the authority to inspect the production of medical products.
The Ministry of Industry and Trade of Russia proposes to allow the unification of various types of medical devices in competitions for the conclusion of offset contracts. The changes were proposed by Moscow Mayor Sergei Sobyanin.
The list of alcohol-containing medical products will be updated more often
The Government of the Russian Federation has approved amendments to the rules for the formation of a list of alcohol-containing medical devices that are not subject to the requirements of Rosalkogolregulirovaniya.
More news: https://en.medstandard.ru/
MedStandard Rus
Main news by Friday March 31
The number of cancelled drug purchases decreased at the beginning of the year
From the beginning of the year to March 27, slightly more than 73 thousand purchases of medicines were canceled or did not take place. A year ago, there were almost 80 thousand of them. This was most often the case when purchasing dextrose, sodium chloride and amoxicillin with clavulanic acid.
The state program “Development of the pharmaceutical and medical industry” was included in the four projects whose level of execution of expenses is less than 95%. In 2022, it amounted to 80.8%, the Accounting Chamber said.
Murashko reported on the introduction of mechanisms to prevent drug shortages
Special mechanisms have been introduced to overcome the shortage of medicines and medical products. There is no global deficit in the country now, the Ministry of Health reported.
More news:
https://medstandard.ru/news/
MedStandard Rus 🇷🇺
Main news by Friday, April 21
The roadmap for the development of the rehabilitation industry is detailed until 2025
The Government of the Russian Federation has approved a roadmap for the development of rehabilitation products for the period from 2023 to 2025.
Roszdravnadzor for the first time issued a permit for the use of an unregistered medical device for in vitro diagnostics “A set of reagents for high-performance sequencing of human biological material in order to detect a wide range of hereditary monogenic diseases (Clinexom)”.
On April 20, the State Duma immediately adopted amendments to FZ-44 “On the Contract System” in the second and third readings, regulating the description in the procurement of medical products and medical nutrition.
More news:
https://medstandard.ru/news/
MedStandard Rus 🇷🇺
Main news by Friday, April 28
A radiotherapy system based on the SHINVA XHA600E linear electron accelerator for cancer therapy has become available on the Russian market. This is the first Chinese accelerator on the Russian market. Before that, the systems of the American Varian (owned by Siemens Healthineers) and the Swedish-British Elekta dominated here.
Decrease in the production of medicines
In the first quarter of 2023, the production of medicines decreased by 9.8% compared to the same period last year. Products worth 152 billion rubles were manufactured.
The Ministry of Health has withdrawn 36 registration certificates
The Ministry of Health excluded from the GRLS 34 registration certificates of medicines and two RU at the pharmaceutical substation. Most of the excluded drugs have analogues on the Russian market.
More news:
https://medstandard.ru/news/
Subscribe on news
Leave your email and be the first to receive the latest company news.