News Digest 04.09.2026 — 11.09.2026
Regulators
Russian Ministry of Health to Update Rules for Importing Medicines into Russia
The Russian Ministry of Health intends to update the rules governing the import of medicinal products for medical use into Russia. A draft resolution is currently undergoing public consultation until September 18.
The current import rules were approved by Russian Government Resolution No. 853 dated June 1, 2021, and are set to expire on September 1, 2027.
The draft proposes a new mechanism: an opinion from the Russian Ministry of Health will no longer be required for the import of unregistered medicinal products used in the manufacture of medical devices. Instead, the manufacturer must obtain confirmation of the import purpose from Roszdravnadzor (the Federal Service for Surveillance in Healthcare). The review period is ten working days, and the issued document is valid for one year.
The list of grounds on which the Russian Ministry of Health may refuse to issue an opinion has been expanded to include two new items: the absence of information about the applicant in the Unified State Register of Legal Entities (EGRUL), and the resubmission of documents regarding a medical commission decision if an opinion had previously been issued for the entire volume of the drug (with the exception of medical commission decisions prescribing drugs for lifelong use).
Changes are also being made to the rules for importing medicines based on vital medical indications. Requirements for the medical commission protocol are being clarified: it must now be signed by the commission chairperson rather than the head of the institution. Furthermore, the exemption regarding document resubmission now applies only to cases where the drug is prescribed for lifelong use; previously, it also applied to long-term therapy.
If approved, the document will enter into force on September 1, 2027, and remain valid until September 1, 2033.
Source: https://pharmvestnik.ru/content/news/minzdrav-rf-obnovit-pravila-vvoza-lekarstv-v-rossiu.html
Market news
Major Chinese CT Manufacturer UIH Enters Russian Tender Market
A government procurement process for the supply of a uCT 780 model CT scanner from the Chinese manufacturer United Imaging Healthcare (UIH) has successfully concluded in Russia. The auction was announced by the Kaliningrad City Emergency Hospital. A contract worth 61.1 million rubles for the supply of the Chinese CT scanner was awarded to the Moscow-based company Garant-Med LLC. The contractor is required to fulfill its obligations by the end of 2026. According to experts, UIH is a significant player holding a substantial market share in the "heavy" medical equipment sector across Europe and Asia. Previously, the company's devices had not been represented in the Russian tender market.
Under the terms of the contract, Garant-Med is required to supply the UIH uCT 780 model CT scanner. This is a 160-slice CT scanner designed for high-precision diagnostics, featuring low noise levels and reduced radiation exposure. According to the operating manual, the system's rotation speed is 0.3 seconds, which improves cardiac scanning quality.
Several foreign companies have begun expanding their presence in the Russian market since the early 2020s: in 2021 and 2022, the Chinese company Anke launched new multi-slice CT scanners and a 1.5T MRI scanner. In 2022 and 2023, the Russian subsidiary of the Belarusian medical equipment manufacturer Adani registered the Ventum 32-slice and 128-slice CT scanners in Russia; these were developed based on a localized version of the Insitum series CT scanners from Sinovision Technologies (China). Additionally, the Dominus CT system from the South Korean company SG HealthCare is currently being prepared for launch on the Russian market.
UIH is a leading manufacturer of heavy medical equipment and diagnostic imaging systems—including solutions for nuclear medicine—based in Southeast Asia and recognized on the global market. The company operates manufacturing facilities in Wuhan and Changzhou, with its headquarters in Shanghai. It maintains regional headquarters in Poland, Malaysia, the USA, Japan, Australia, Morocco, South Korea, and South Africa. UIH medical equipment is supplied to 60 countries worldwide.
Other
China Launches "Personal Medical Cloud" to Transform Healthcare System
China’s National Healthcare Security Administration (NHSA) has announced the launch of a major "personal medical cloud" project, which will be a priority initiative under the 15th Five-Year Plan (2026–2030). The initiative aims to transform vast datasets regarding insurance contributions and medical services into an intelligent support system for 1.33 billion insured citizens.
Built upon a unified national health insurance information infrastructure, the platform aggregates and processes data throughout the entire lifecycle—from system registration and medical treatment to the purchase of medications. For end-users, the project promises three key improvements. First, based on individual profiles, the system will provide personalized expenditure analysis, medication therapy management, and treatment recommendations, as well as an intelligent chatbot to streamline interactions with insurance services.
Second, the cloud storage will allow patients to grant doctors access to their complete medical history—including imaging, pathology reports, lab results, and allergy information—regardless of where they received care; this will significantly reduce waiting times and out-of-pocket expenses. Third, oversight of insurance fund spending will be strengthened: the system will track each of the more than 8 billion annual transactions (totaling over 3 trillion yuan), ensuring full payment traceability and the rapid detection of fraud.
The NHSA has called on enterprises and research institutions to collaborate on developing the cloud platform, emphasizing that joint efforts in digital intelligent technologies can create a robust foundation for safeguarding the health of all citizens. The project marks a shift from fragmented insurance records to a unified, intelligent, and secure service that makes healthcare more accessible, transparent, and patient-centric.
China Approves World’s First AI-Developed COVID-19 Drug
China’s National Medical Products Administration (NMPA) has approved Mprosevir (iscartrelvir hydrochloride) for the treatment of mild to moderate COVID-19 in adults. According to the *Global Times*, it is the world’s first drug created using DNA-encoded library (DEL) technology.
The drug was developed by Westlake University and the pharmaceutical company Westlake Pharmaceuticals. To identify the active ingredient, they utilized a DEL containing 49 billion molecules, selecting the hundred most promising candidates. While evaluating the efficacy of each candidate using standard methods would have required significant time and effort, an AI model narrowed the list down to the nine most promising compounds in just a few days. Clinical trials concluded just 3.5 years after the molecule with the best pharmacological characteristics was identified—a record-breaking timeframe for the pharmaceutical industry, where such processes traditionally take 10 to 15 years. Machine learning technologies were reportedly employed at every stage of development, not just during the initial molecule screening.
Mprosevir is a non-covalent inhibitor of the 3-chymotrypsin-like protease (3CLpro)—a key enzyme in coronaviruses, including SARS-CoV-2, that is essential for viral replication within human cells. Due to its high potency, the drug can be administered without boosters like ritonavir, which are typically added to similar medications to slow their hepatic metabolism; this reduces the risk of adverse drug interactions. 3CLpro is also targeted by nirmatrelvir—a component of Paxlovid, the drug from pharmaceutical giant Pfizer that first entered the US market in 2021—and by leritrelvir from the Chinese company Raynovent, which was registered by the NMPA as Leruiling in 2023.
Source: https://pharmvestnik.ru/content/news/kitai-odobril-pervyi-v-mire-ii-preparat-ot-covid-19.html
Sleep-supporting gummies launched featuring a peptide discovered via AI
British personalized nutrition brand Nourished (part of the Rem3dy Health group) has introduced a new product, Sleep Pro—sugar-free gummies designed to support sleep. It is the first consumer product on the UK market to feature PeptiSleep, a plant-based peptide derived from rice bran protein using the Nuritas AI platform, which specializes in identifying bioactive compounds. The product utilizes Nourished’s proprietary 3D printing technology, which allows multiple active ingredients to be combined into a single gummy.
The Sleep Pro formula contains a clinically studied dosage of PeptiSleep (250 mg) combined with Vitamin C, cherry extract, zinc, B vitamins (B1, B6, B12), and Vitamin D3. According to the company, PeptiSleep helps improve all stages of sleep by lowering cortisol levels. In a clinical study involving adults with mild to moderate sleep disturbances, a daily intake of 250 mg of the peptide resulted in a 17% increase in deep sleep duration, a 13% increase in REM sleep, and an increase in total sleep time of approximately 40 minutes per night. Participants also showed improved next-day recovery metrics, as measured by wearable devices.
The company emphasizes that PeptiSleep works via a non-habit-forming mechanism by regulating peripheral cortisol levels, unlike ingredients that artificially induce drowsiness. This is particularly relevant for the UK market, where melatonin—widely available in the US and parts of Europe—cannot be sold as a dietary supplement and is available only by prescription for specific medical conditions. Thus, Sleep Pro fills a niche for scientifically backed, hormone-free solutions for improving sleep.
New registered medical devices
We publish a list of new medical devices registered from 09.04.2026 to 09.11.2026
Link to the list: [see table in the attachment]
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