News Digest 11.09.2024 — 13.09.2024
Regulators
The government has extended the simplified procedure for confirming the certification and declaration of products
The government has extended until September 1, 2025 the simplified procedure for confirming the compliance of products with the requirements of technical regulations, as well as national and interstate standards when importing them from abroad or putting them into circulation in the country. Resolution No. 1196 of August 31, 2024 was published on the official portal of legal acts.
The amendments are made to RF Government Resolution No. 353 of March 12, 2022 "On the specifics of licensing activities in the Russian Federation in 2022". The document allows manufacturers and exporters of goods that require a lengthy certification procedure to use a simplified procedure. This procedure applies, among other things, to medical products, hygiene and disinfectants, as well as cosmetics.
"This procedure has reduced the risks of low-quality products entering the market and, at the same time, reduced the burden on businesses. The measure taken under the conditions of sanctions has proven its effectiveness, so it was decided to extend it,” the government emphasized.
In April 2022, the government simplified the procedure for registering medicines. The adopted document established the specifics of the circulation of medicines for medical use in the event of a shortage or risk of a shortage of medicines due to the introduction of sanctions. The period for state registration and examination of the quality of medicines was reduced by 30 days. Initially, this rule was valid until the end of 2023. Then it was extended for a year.
“Due to external restrictions imposed on our country, many supply chains have been disrupted. To enable drug manufacturers to bring them to the domestic market faster, the government will extend the application of a number of simplified procedures until the end of next year,” Prime Minister Mikhail Mishustin said a year ago.
Market news
Hematology Center to receive 82.3 million rubles for equipment for high-tech drugs
The government will allocate 82.3 million rubles to the National Medical Research Center for Hematology of the Ministry of Health to equip it with equipment for the development and production of high-tech drugs. Order No. 2462-r of 11.09.24 on the purchase was signed by Prime Minister Mikhail Mishustin.
The funds allocated from the reserve fund will be used to purchase “at least 39 units” of modern equipment. Its list is not published. The Ministry of Health will monitor the purchase with a report by February 1, 2025.
“The development and production of new drugs is one of the main goals of the Strategy for the Development of the Pharmaceutical Industry until 2030, approved by the government in 2023. It is aimed at providing the domestic market with modern domestic medicines and meeting the needs of citizens for essential drugs,” the government press service said in a statement.
Imbian Lab invested 210 million rubles in the production of medical devices and dietary supplements in the Krasnodar Territory
The Novosibirsk and Moscow manufacturer of express tests, Imbian Lab, invested 210 million rubles in the production of medical devices - express tests, as well as dietary supplements (dietary supplements) and herbal preparations - at the facilities of the reconstructed Repair and Mechanical Plant (RMZ) in Slavyansk-on-Kuban, Krasnodar Territory. After reaching its design capacity, the enterprise plans to produce more than 200 thousand products per year. The total investment in the project is estimated at 3 billion rubles. The company is implementing a project to create a production facility for medical products - rapid tests, as well as herbal preparations and dietary supplements. The agreement, which provides for an investment project with a total investment of 3 billion rubles, was signed in January 2023.
The facility is currently being reconstructed. Since the start of the project, 210 million rubles have been invested. In July 2023, the company began producing dietary supplements in the form of herbal tea at the enterprise. In total, the company is developing two lines of dietary supplements under the brands "Imbian ECO" and "Imbian Pharm".
According to SPARK-Interfax, Imbian Lab LLC was initially registered in Novosibirsk in 2019. The company specializes in the development and supply of diagnostic kits using enzyme-linked immunosorbent assay (ELISA), immunochromatographic (ICA) methods, as well as the polymerase chain reaction (PCR) method. The supplier's portfolio includes rapid tests for antigen and antibodies to the SARS-CoV-2 coronavirus, medical tests for hepatitis C, urogenital and TORCH infections under the Imbian brand. The company is developing its own immunochips - test systems for the simultaneous detection of antibodies and antigens to pathogens of various types of infections in human serum and plasma. In the spring of 2022, the company changed its jurisdiction to Moscow and also announced the localization of rapid tests for COVID-19, rapid tests for hepatitis B and C in the Technopolis Moscow SEZ with a total investment of 400 million rubles. That same fall, the legal entity Imbiane Lab was included in the register of unscrupulous suppliers. The decision was made on October 7, 2022, by the St. Petersburg Office of the FAS. The reason for inclusion was the "evasion of the winner from concluding the contract", according to the register card, but the company appealed the decision and in February 2023 achieved exclusion from the register.
"Diakont" invested 1 billion rubles in the production of domestic insulin pumps
The domestic manufacturer of medical devices for patients with diabetes mellitus "Diakont" is preparing to launch the production of insulin pumps and biosensors for monitoring blood glucose levels in Korolev, Moscow Region. The capacity of the new workshop is 10 thousand insulin pumps and about 1.5 million units of consumables - insulin reservoirs and catheters. In the future, the company intends to expand the production volume, as well as begin to produce analogs of consumables for insulin pumps of leading European manufacturers. The volume of investments in the project is estimated at 1 billion rubles. At the first stage, Diakont intends to produce about 10 thousand insulin pumps and at least 1.5 million consumables - insulin reservoirs and catheters per year. In the future, this volume will be increased several times. Options for export deliveries to "friendly" countries, including Serbia and Greece, are being worked out. Diakont received product validation in Roszdravnadzor, follows from a message from the Ministry of Investment, Industry and Science of the Moscow Region. The company plans to release the first batch of insulin pumps by the end of this year.
The Diakont company was founded in 2001. The developer has been conducting research and development work and has been manufacturing medical products for patients with diabetes since 2005 in cooperation with Moscow State University and the Pushchino Scientific Center for Biological Research of the Russian Academy of Sciences. In 2010, Diacont opened production of Diacont glucometers and Unistrip1 test strips in Russia - an analogue of the original Johnson & Johnson One Touch consumables. According to the founder and promoter of the company Petr Shishko, the main enterprise of Diakont is located in Southeast Asia, where 750 million packages of products are produced per year. In Russia, Diakont produces test strips for determining glucose levels in patients with diabetes at its own site in Korolev, Moscow Region. The capacity of the enterprise is 15 thousand packages of finished products per year.
The project to localize the production of test strips, glucometers, glucose sensors and insulin pumps by Taiwanese OK Biotech in the Moscow Region became known in the fall of 2022. It was assumed that the investment project would be implemented from January 2023, the capacity of the site would be 300 million packages of products per year.
Other
To date, 37 AI-based medical devices have been registered in Russia
Thirty-seven medical devices based on artificial intelligence have already been registered in Russia, and this year the goal is to introduce at least three such medical devices in each region of the country, said Deputy Minister of Health of the Russian Federation Vadim Vankov.
Source: https://ria.ru/20240903/minzdrav-1970128709.html
The Ministry of Health was offered to automate patient consent to the transfer of data for training AI
Lawmakers recommended that the Ministry of Health introduce a mechanism for automatic patient consent to the transfer of their anonymized medical data for training artificial intelligence (AI) when receiving assistance under compulsory medical insurance. The proposal came from the Artificial Intelligence section of the Federation Council, Deputy Chairman of the Council for the Development of the Digital Economy under the upper house of parliament Artem Sheikin told TASS.
He clarified that such a requirement is planned to be extended to private clinics where citizens receive medical care under the compulsory medical insurance.
In addition, parliamentarians and experts of the section propose to study the issue of creating mechanisms for simplified implementation of products using AI and robotics technologies, as well as developing mechanisms and methodologies for calculating the amount of funding for each request to an AI service in healthcare. At the same time, it is proposed to clarify the legal status and distribution of responsibility when using AI between the doctor, the developer, the medical organization and the certification body.
Newly registered medical devices
We publish a list of new medical devices registered from 09.06.2024 to 09.13.2024
Link to the list: [see table in the attachment]
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