Roszdravnadzor has imposed a fine of 130 thousand rubles on a spa resort in Yessentuki for improper storage of medical products…

In 2015, Roszdravnadzor restored the rights of more than 460 thousand citizens to effective, accessible, and safe medical…

Roszdravnadzor informs that the certification scheme for products in the Russian Federation is determined by Decree of the…

In one and a half months of 2016, the Local Agency of Roszdravnadzor in Rostov Region imposed fines of the total amount of…

Two citizens were fined for selling unregistered medicinal products on the Internet in the Republic of Bashkortostan.

Roszdravnadzor started an unscheduled inspection of the Federal State-Funded Institution of Sverdlovsk Region Kirovgrad Central…

The delegation of the Federal Service for Surveillance in Healthcare headed by Mikhail Murashko, Head of Roszdravnadzor,…

Roszdravnadzor has suspended a series of the preparation “Paratsetomol-UBF” in which pills the metal wire was found.

Roszdravnadzor (RZN) statement: the expensive medical equipment for the total amount of 342 million rubles stands idle in…

Roszdravnadzor has audited the activity of the Regional Budgetary Public Health Facility “Central district hospital of Lenin”…

Mikhail Murashko has made the presentation at the cabinet meeting at the Chairman of the Soviet of the Russian Federation…

The delegation of Roszdravnadzor has taken part in the work of the Forum “Human Health — a Basis of Successful Russian Development…

Roszdravnadzor will conduct unannounced desk searches in the fact of the retiree’s death, according to media sources, he…

Roszdravnadzor has revealed the fabricated ultrasound investigation apparatus in the private clinic of the Samara region.

On June 16, 2016 in Roszdravnadzor there is the enlarged meeting of Community council on defense of patients’ rights in case…

Roszdravnadzor warns: cosmetic services with the use of hyaluronic acid and botulinum toxin type A (trade names Botox, Dysport,…

On June 16, 2016 in Roszdravnadzor (RZN) for the first time in the mode of a video conferencing the enlarged meeting of Public…

In Roszdravnadzor the seminar for domestic producers on the questions of the pre-qualification requirements of WHO to medical…

Roszdravnadzor has taken part in the international preventive operation “Pangea”, aimed at curbing the illegal trade in drugs…

The process of renewal of old registration certificates has been completed and according to the law

26 drugstores of the Stavropol Territory are fined by Roszdravnadzor for realization of drugs intended for the induced termination…

Roszdravnadzor analyzed the efficiency of operation of medical equipment in the context of territorial entity of the Russian…

In connection with the spread in the mass media on the growth of retail prices of drugs from the list of VED, Roszdravnadzor…

The local authority of Roszdravnadzor for Moscow and the Moscow region has stopped activities of an illegal dental office.

Roszdravnadzor has begun check in the city hospital of the Khabarovsk Territory where, according to mass media, doctors have…

Roszdravnadzor: in the first half of 2016 the number of citizens’ complaints to provide analgesic drugs decreased by 1.4…

On July 8, 2016 in the Federal Service for Surveillance in Healthcare under the chairmanship of the head of Service Mikhail…

CU TR 009\2011 for beauty product is a part of EEU regulation - under EAC mark - applied for beauty products in common meaning…

Roszdravnadzor has begun the check upon the death of one-year-old child in Spassky district hospital (the Republic of Tatarstan)

The head of Roszdravnadzor Mikhail Murashko has visited the Far Eastern Federal District with the working visit

On July 21, 2016 the meeting of the board of Roszdravnadzor devoted to the implementation of the performance appraisal…

In connection with the media-disseminated information about possible problems in the medical device market in 2017, Roszdravnadzor…

The powers of the Federal Service for Surveillance in Health Care (Roszdravnadzor) include the registration of medical devices…

The Roszdravnadzor office in the Samara Region conducted an extraordinary documentary inspection of the state-run health…

The Federal Service for Surveillance in Healthcare (Roszdravnadzor) holds a workshop titled “Monitoring of the Safety, Quality,…

A memorandum of understanding on co-operation in the area of medicines and medical devices between the Russian Federal Service…

A delegation of the Federal Service for Surveillance in Healthcare led by its head, Mikhail Murashko, participated in the…

An individual entrepreneur was punished under criminal law in the Samara Region for wholesaling unregistered medical products.In…

The head of the Federal Service for Surveillance in Healthcare, Mikhail Murashko, participated in the National congress “Immunobiological…

Rostov Region’s healthcare organizations and pharmacies to pay RUB 11 mln. for violations revealed by Roszdravnadzor’s territorial…

Roszdravnadzor’s head Mikhail Murashko took part in the 2nd International Conference on Development of Palliative Care for…

As part of the Medicine and Quality 2016 conference, the Federal Service for Surveillance in Healthcare (Roszdravnadzor)…

Roszdravnadzor checks Elizavetinskaya Hospital in Saint-Petersburg where, according to mass media reports, stabbed female…

The Chief Sanitary Officer of the Russian Federation has signed a decree No. 195 On Suspension of Retail Trade of Non-Food…

During Christmas holidays, 45 citizens from 30 regions of the Russian Federation contacted Roszdravnadzor’s hotline. The…

Roszdravnadzor will look into the incident in an Ufa city polyclinic in which an elderly woman with her leg in plaster had…

Roszdravnadzor shuts down three illegal medical centers of Chinese medicine in the city of Sochi, the Moscow region and in…

Roszdravnadzor will look into the fact of a failure to provide timely medical assistance in the Mariinsky hospital in St.…

Roszdravnadzor will check the timing of healthcare provided to a woman in labor in the town of Kemerovo, who, according to…

The Resolution of the Russian Government named “On performance of the experiment for labeling with control (identification)…

On January 30, 2017, the Government of the Russian Federation published its resolution dated January 24, 2016, bearing No.…

The territorial body of the Russian Federal Service for Surveillance in Healthcare for Moscow and the Moscow Region will…

Exercising control over the pharmaceutical provision of patients, including distribution of anti-retrovirus preparations,…

The term of validity of registration certificates for infinite medical devices was prolonged until 2021. The relevant resolution…

Roszdravnadzor’s Head Mikhail Murashko attended the final session held by the expert panel of the Krasnoyarsk Krai Ministry…

Head of the Federal Service for Surveillance in Healthcare Mikhail Murashko made an on-site visit to the Krasnoyarsk branch…

As per Order of the Ministry of Public Health and Social Development of Russia No. 277n dated 27.05.2009, as of May 2009…

Roszdravnadzor’s Head Mikhail Murashko took part in the “Made in Russia – Recognized Abroad” Forum and spoke about the new…

The head of Roszdravnadzor Mikhail Murashko answered questions from the leaders of pharmaceutical companies during a business…

The Federal Service for Surveillance in Healthcare is inspecting the Altai Krai Ministry of Public Health and the Barnaul…

Roszdravnadzor will conduct an investigation into the death of a five-year-old child in Moscow, who died at home due to complications…

More than 1.5 thousand people took part in the work of the webinar on the treatment of pain and the availability of narcotic…

The local health authority of Roszdravnadzor for Rostov region carried out a planned inspection of the municipal budgetary…

Decrees of the Ministry of Healthcare of the Russian Federation approving the Rules of good pharmacy practice and good drug…

22/02/2017 During a working visit to the Krasnoyarsk Krai, Roszdravnadzor’s Head personally checked the level of the preparedness…

Roszdravnadzor reveals gross violations at Ivanteevka Central Municipal Hospital (Moscow Region) over the death of a 14-year-old…

A meeting of the Consultative Group of the General European Official Medicines Control Laboratories Network (GEON) held on…

By instruction of Minister of Health of the Russian Federation Veronica Skvortsova, Roszdravnadzor will hold an inspection…

Roszdravnadzor Head Mikhail Murashko attends a panel meeting of the Kaluga Region Ministry of Health and inspects regional…

Roszdravnadzor cooperates with prosecution authorities to prevent illegal sale of unregistered high-technology medical devices…

Roszdravnadzor checks the quality of medical assistance to a female patient, who died after a plastic surgery at the Moscow…

An interview of the head of the Federal Service for Surveillance in Healthcare with the Russian-Belorussian channel TRO.

The Federal Service for Surveillance in Healthcare is to investigate the case of death of a patient of the Volgograd clinical…

More than 3.2 thousand people participated in a webinar of the Federal Service for Surveillance in Healthcare devoted to…

Federal Service for Surveillance in Healthcare: On March 24, 2017, the approved requirements to keeping of technical and…

On March 22, 2017, a meeting of the Community Board for Patient Right Protection at the Federal Service for Surveillance…

The interview of the Head of the Federal Service on Surveillance in Healthcare and Social Development of Russian Federation…

The interview of the Head of the Federal Service on Surveillance in Healthcare and Social Development of Russian Federation…

Mikhail Murashko personally checked the implementation of the Roszdravnadzor recommendations by Altai regional clinical perinatal…

The Federal Service for Surveillance in Healthcare carried out a joint workshop with the World Bank experts on developing…

The 70th World Health Assembly (WHA) opened in Geneva (Swiss Confederation). WHA is the supreme governing body of the World…

The Federal Service for Surveillance in Healthcare, within its scope of authorities, carries out supervisory activities in…

Despite the fact that some manufacturers have complained on the difficulties arising from medicine labelling being introduced,…

An authorized representative of the manufacturer’s brand of condoms Durex – LLC “Reckitt Benckiser Helsker”

Roszdravnadzor delegation headed by Chief Executive Mikhail Murashko paid a business visit to People’s Republic of China…

Pharmaceutical benefits under the state social assistance program.

Roszdravnadzor regional agency for Samara region will hold an unscheduled inspection of the private dental clinic Practika…

On July 27, the Federal Service for Surveillance in Healthcare chaired by the Head of Roszdravnadzor Mikhail Murashko held…

In response to inquiries coming in from the media and the professional pharmaceutical community regarding the bill “On the…

With reference to the letter about the application of exemption from value-added tax (the tax rate of 10 per cent) to medical…

Roszdravnadzor discovered violations in State Budgetary Healthcare Institution of Stavropol Territory “Municipal Clinical…

Roszdravnadzor summed up the preliminary results of implementation in 16 regions of the country of the Proposals of the Service…

In the hospital of the city of Azov (Rostov region), patients with strokes were illegally sent for paid examinations.

Patients with strokes in a hospital of Azov (Rostov Region) were illegally referred to paid examinations. Based on the Roszdravnadzor…

Due to the activities of Roszdravnadzor (Federal Service for the Supervision of Public Health and Social Development) in…

Roszdravnadzor together with law enforcement authorities prevented illegal distribution of falsified, unregistered and counterfeit…

As of December 12, 2017, resolution of the Government of the Russian Federation as of 18/12/2016 No. 1327 shall enter legal…

The Regional Dental Health Centre of Vladimir Oblast fined 200,000 roubles for violations identified by the Federal Service…

Roszdravnadzor: couriers involved in trafficking of unregistered medicinal products sold by online stores have been fined…

The transfer of Russian economics to Eurasian Economic Union leads on the changes in the routines of State registration for…

Nowadays a lot of ingredients, such as: Polyethylen, Polypropylen, PET, etc. can be found in cosmetics. What lies behind…

Software as a Medical Device (SaMD), in other terms – «software intended to be used for one or more medical purposes that…

In March 2017, Order 11n “On the Approval of the Requirements Imposed on the Contents of the Technical and User Documentation…

Dear colleagues, we will start our journey into the secrets of Russian standards, concerned with medical devices with a short…

At the present time registration of medical devices containing pharmaceutical substances is the topic for discussion for…

The standard, that regulates this number in Russia is GOST 31214. And its actual version is GOST 31214-2016 (started from…

Due to the increased number of complications occurring to patients after cosmetological interventions, Federal Service for…

Today, medical and surgical specialists note the increased number of complications occurring to their patients as a result…

According to statistics, 40% of patients of surgical departments in Russian hospitals are individuals with wounds. In this…

Traditionally injectable cosmetological procedures are divided into four main groups: Botulinum Toxin Therapy, Biorevitalization,…

Dear colleagues, in this article we give to you the explanation about reasons of using standards of GOST range during the…

There are substances in our body that can destroy different cells and useful compounds. They are called free radicals. For…

Sunscreens are an integral part of protection against aggressive solar radiation. The modern market of cosmetic products…

In one of previous articles we discuss quantity of medical device samples for toxicological testing (biocompatibility trials).…

A project to improve the quality of work of healthcare organisations has been launched in the Republic of North Ossetia-Alania.…

The CEO of the chart paper factory in Belgorod received a criminal term for the manufacture and distribution of an unregistered…

Thanks to the united actions of Roszdravnadzor and law-enforcement agencies in the territory of the Russian Federation, the…

The manufacturer was fined 500 thousand roubles for supplying unregistered medical oxygen to a medical institution in Rostov.…

Nowadays the market for biomedical cell products (BMCP or BCP) is a rapidly growing branch of the global economy. This is…

Today we speak about some easy but necessary rules in Russia - labeling, marking of medical devices must comply with in order…

In one of the previous articles we discussed necessary symbols, that must contain label of medical devices for state registration…

Parabens are widely used in the cosmetic, pharmaceutical and food industries as preservatives. Their use is not prohibited…

This is is very popular question from our customers - which company name must be written in hard copy of registration certificate…

The Federal Service for Surveillance in Healthcare informs about the adoption of the decree of the Government of the Russian…

Labeling of accumulators as a part of medical devices is required - full information in our new technical regulation issue.

Amendments for Order of Russian Government 1416 were done - and this 4th issue is the most significant from 2013 year.

The state marketing authorisation of medical devices (medical device registration process) in the Russian Federation is carried…

After receiving information about the death of the woman after planned plastic breast surgery in the OOO Elit Clinic company…

GOST R 50444-92 (equivalent to GOST 20790-93) is an important standard for many types of medical devices in Russia, and is…

Federal Law No. 140-FZ dated June 04, 2018 On Amendments to the Federal Law On the Circulation of Medicinal Products entering…

In connection with the recent tragic events attributed to plastic surgery, the Ministry of Healthcare of the Russian Federation…

There is a standard GOST 15150 in Russian Federation, which regulates climatic conditions of manufactured devices. It contains…

Legal entities and/or private entrepreneurs intending to perform work (services) in the field of medical device circulation…

There are a few groups of medical devices, which have pharmaceutical substances in their composition. For example, filers…

Currently, there is data on the development and patenting of more than 700 biomedical cell products (BMСP) for the treatment…

In late May, the Government of the Russian Federation approved regulation 633 "On amendments to the Rules of State registration…

Russian Federation is the biggest country in the world by territory and it looks like telemedicine could be solution for…

The Federal Service for Surveillance in HealthCare reminds you that consultancy services for applicants regarding marketing…

In the section "Biomedical cell products" of our web site there were published a lot of articles, devoted to the analysis…

FGBU CMIKEE of the Federal Service for Surveillance in HealthCare will hold professional postgraduate education training…

Order № 633 "On the introduction of amendments to the Rules of state registration of medical devices" came into force in…

In the medical device market, there is a large number of products that contain various chemicals in the composition - active…

Clinical investigations (CIs) of biomedical cell products (Biomedical cell products) are an integral part of the registration…

Among the exceptional diversity of medical devices varying in their purpose, mechanism of action, design properties, complexity,…

On October 8, 2018, during the XXth Annual All-Russia Conference with International Participants “State Regulation of the…

After implementation of Federal Law, No 242-FZ dated 07.29.2017 “On the implementation of changes in certain legislative…

An extensive group of medical devices (MDs) includes completely different products that may include different components.…

The Russian government has introduced a temporary permitting procedure for the import into the Russian Federation of biomedical…

In the section devoted to biomedical cell products, much attention was paid mainly to the legal aspects of the circulation…

In the first article of this heading general principles of certification of dietary supplements within the Customs Union…

All medical devices circulating within the territory of the Russian Federation are subject to safety monitoring. One of…

The labeling of medical devices shall be a matter of crucial importance for the design, development, manufacturing and virtually…

In the section on the application of biomedical cell products (BMCP), a great deal of attention was paid to the various aspects…

Certification of dietary supplements does not do without the development of regulatory documentation for the product. For…

In April 2019, within the framework of the IPhEB Russia exhibition, held in St. Petersburg, a thematic session “Development…

Following the last session on biomedical cell products (BMCP) within IPhEB 2019 (read more in the article), there was published…

On 19 April 2019 the territorial body of the Federal Service for Supervision in Healthcare in Moscow and the Moscow region,…

As a result of control and supervisory measures the territorial body of the Federal Service for Supervision in Healthcare…

Our new topic about drugs regulation: what are drugs and how to determine it from borderline products? how to receive state…

Nowadays, we can often hear that certain cosmetic products do not contain parabens and silicones. About what parabens are,…

Declaration of perfumery and cosmetic products on the territory of the customs union becomes a difficult task for foreign…

Which problems photonics regulation has? By link - article from magazine about current situation in this area. Main players…

As part of the consideration of the procedure for registration of medicines it is worth paying attention to such groups of…

Not so long ago on our site there were published several articles devoted to the most sensational categories of substances,…

Not so long ago it became known that the American biopharmaceutical company AbbVie became the lucky owner of the Irish manufacturer…

Order of the Ministry of Health of the Russian Federation (Minzdrav Rossii) dated 9 January, 2014 No. 2n “On Approval of…

According to the All-Russian Society of Orphan Diseases, about 30 million patients with rare diseases were registered in…

Autoimmune diseases (AID) develop in cases where antibodies (AT) or T cell clones are present in the body, directed against…

For many people, it sounds strange, but the skin is the biggest organ of our body, which is exposed to the strongest environmental…

Testing of a medical device for the purposes of marketing authorisation, particularly on-site visits as one of the testing…

Development of new drugs is a long-term and expensive process. According to J. A. DiMasi et al, the development and implementation…

Technical testing and toxicological testing of medical devices should be carried out in a testing laboratory with the appropriate…

The invention of the laser became one of the most important and significant achievements of the twentieth century. Currently…

According to the Deputy Head of the Research Institute of Clinical and Experimental Lymphology for scientific work, Doctor…

Tests conducted for the purposes of the state registration of medical devices are regulated by Order No. 2n dated 09 January…

The reliability and accuracy of the sample results in clinical laboratory tests are influenced by many factors, such as the…

Perhaps nothing so objectively reflects the reality as figures. Of course, if the numbers are real. They can scare, please,…

According to the Federal Law No. 61 “On Circulation of Medicines”, a drug, first entered the Russian market, receives a registration…

First registration certificate under EAEU regulation was issued in the end of December 2019: registration certificate is…

More than a year has passed since our latest publication dedicated to CAR-T therapy — cell products belonging to the BMCP…

In the section devoted to biological active additives (BAS), several articles were published about the “Russian” view of…

In the section devoted to biological active additives (BAS), several articles were published about the “Russian” view of…

According to the official website of the Federal Accreditation Service, 1,461 perfumery and cosmetic products (PCP – if shortly)…

Currently, under the national registration procedure, drugs can be divided into three groups: original, generic and immunobiological…

A drug is a complex multicomponent system that consists not only of the active substance (active pharmaceutical ingredient,…

The Federal Service for Surveillance in Healthcare (Roszdravnadzor) belongs to the executive authorities and performs control…

The Ministry of Internal Affairs of the Russian Federation has awarded three officers of the Federal Service for Surveillance…

The Federal Service for Surveillance in Healthcare will investigate into the intra-uterine fetal death of a 16-year old girl’s…

Clinical Study Part for BMCP was last updated on our website in 2018. This is because no special events have occurred since…

Blockchain technology (BT) became popular with the development of cryptocurrency bitcoin in 2009. From that moment on, interest…

According to the Clinical Recommendations for Iodine Deficiency Diseases and Conditions, there are no territories in Russia…

Often, food advertisements have the following phrases: “enriched with probiotic” or “contains prebiotics.” These two words…

Order of Russian Government 430 (registration scheme for emergency COVID medical devices and IVDs, was prolongated to 2021)…

Humanity now uses a huge number of biotech drugs without thinking about their origin and production process. Such drugs include,…

The covid-19 pandemic was a catastrophe of the 21st century, not only for humanity, but for planet Earth as a whole. Due…

In early October, the State Register of Medicines (GRLS) revealed the suspension of a number of ranitidine drugs intended…

List of changes in standards for medical devices (most applicable by Company BW experience) for period January 2021 till…

On the approval of specific features of the circulation, including specific features pertaining to the marketing authorisation,…

With the entry into force of the EAEU registration rules, the classification of drugs has changed significantly, as we wrote…

As you know, in the near future, namely from January 1, 2022, the five countries of the Eurasian Economic Union will be united…

From January 01, 2022, registration of a medical device (MD) under the national procedure will not be possible. This will…

According to Decision No. 46 “On the Rules for Registration and Examination of Safety, Quality and Effectiveness of Medical…

From 2022, as part of MD registration according to the requirements of the EAEU, for products of risk classes 2a (sterile…

Updates in standards for the period November - December 2021

Government fees for initial registration process as medical device consists of

In the previous article we analysed in detail the foreign and domestic definitions of the concept of a wearable device. Now…

To date, oxygen cosmetics is one of the most popular categories of cosmetic products. Of course, oxygen is necessary for…

At 1st of March standard GOST ISO 10993-1-2021 was updated, main changes in our review:

In recent years, clinical laboratory diagnostics have received a big leap in their development, whose is the main task detection…

It's not a secret that the composition of the drug includes two components: the active pharmaceutical ingredient (API) and…

On the website of the Federal Service Rosddravnadzor, the first list of type codes to the Decree of the Government of the…

In the previous article, we reviewed new registration procedures specific to certain drugs in accordance with the requirements…

Many pharmaceutical workers involved in the regulatory activities remember the times when a drug dossier was brought to the…

Factory audit during registration process and amendments became a reality not only in EAEU regulation but in national registration…

List of type codes dated June 28, 2022 based on the results of a meeting of the interdepartmental commission on the formation…

Currently, the pharmaceutical sector is one of the priorities for development in Tajikistan. In 2020, the government of Tajikistan…

The Republic of Belarus, along with Kazakhstan, Kyrgyzstan, Armenia and Russia, is part of the EAEU. This is of great importance…

It's not a secret that registration of a medicinal product is a long and laborious process. In this regard, in many countries…

In the spring of 2022, in connection with the introduction of economic restrictive measures against the Russian Federation,…

The state registration system in the Republic of Kazakhstan is quite similar to the registration system in the Republic of…

In Russia, there is a risk of disappearance of tests for genetic breakdowns and oncological diseases. According to information…

Recently, the Order of the Ministry of Health of the Russian Federation No. 685p of October 21, 2022 “On Amendments to Certain…

Approaches to the regulation of in vitro diagnostic (IVD) medical devices vary by country. For example, in the United States,…

In the United States, the Food and Drug Administration (FDA) regulates medical devices (including in vitro diagnostic devices).…

A Pre-Submission includes a formal written request from a submitter for feedback from the FDA which is provided in the form…

The purpose of the medical device classification according to the requirements of US law is to obtain a seven-digit code,…

Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket…

In the previous part of the article, we considered the purpose of premarket notification procedure, as well as what is meant…

On December 7, 2022, Government Decree N 2240 " On approval of the rates of import customs duties for certain goods, the…

On June 23, 2022, an innovative HIV drug called Sunlenca (lenacapavir) manufactured by the American company Gilead was approved…

According to the register of medicines in the Russian Federation, there are 218 drugs containing paracetamol as an active…

On December 22, 2022, Regulation of the Government of the Russian Federation No. 2374 dated December 22, 2022 "On amendments…

In December 2022, it became known about deaths among children in neighboring countries associated with taking an Indian drug…

In December 2022, it became known about deaths among children in neighboring countries associated with taking an Indian drug…

On August 18, 2022, Rospotrebnadzor sued the founder of the Wildberries marketplace, Tatyana Bakalchuk. The reason for going…

One of the articles in the US medical device registration section was devoted to the PMA (premarketing approval) procedure.…

Hemophilia B is an inherited disease that results in a malfunction of the gene that regulates the synthesis of blood coagulation…

In 2022, the Government of the Russian Federation developed a number of regulations regarding the circulation of medicines…

Regulatory affairs specialists often come across the concept of grace period. For an ordinary consumer who buys a particular…

Researchers classify POC-systems according to different parameters: application, operating principle, device, etc., because…

Currently, the State Duma is considering a draft law on amendments to the Federal Law "On the Circulation of Medicines" and…

In November 2022, Roszdravnadzor received a notification from the Novo Nordisk manufacturing company about the planned termination…

Rospotrebnadzor plans to amend the technical regulations of the Customs Union "On food safety" (TR CU 021/2011) and "On the…

As part of the implementation of Decree of the Government of the Russian Federation No. 2026 dated November 24, 2021 “On…

At the beginning of April 2023, a letter was published on the website of Roszdravnadzor for healthcare professionals about…

In April 2023, the Ministry of Health of the Russian Federation issued Order No. 95n, which simplifies the procedure for…

It would seem nothing. However, at the end of February, amendments to Federal Law No. 53 of June 1, 2005 “On the State Language…

The Unified Customs Register of Intellectual Property Objects of the Member States of the Eurasian Economic Union (hereinafter…

Point-of-car (POC) diagnostics becomes increasingly popular in nowadays medicine. In Russia, there is no exactly corresponding…

Regarding the national registration of medical devices in the Russian Federation, it is often clarified - is registration…

On May 2, 2023, the Ministry of Health of the Russian Federation approved the procedure for importing medical devices for…

At the end of May 2023, a letter from the Ministry of Health and the expert center of the Federal State Budgetary Institution…

In May 2023, a letter regarding the safety of proton pump inhibitor drugs containing omeprazole, pantoprazole, rabeprazole,…

The PharmComm company, the owner of the exclusive rights to the Bezornil® trademark, found pages of sellers on marketplaces…

From 03/01/2022, within the framework of Decree of the Government of the Russian Federation of December 27, 2012 No. 1416…

In May 2023, Decision No. 60 “On Amendments to the Rules for Registration and Examination of Medicinal Products for Medical…

At the end of June 2023, a letter from the Ministry of Health of the Russian Federation was published on the GRLS website…

In our section devoted to dietary supplements, the topic of insufficient control over the production and circulation of this…

In August 2023, Government Decree (GD) No. 1332 was published, containing information on changes to the Regulation on Maintenance…

In March of this year, in our column dedicated to biomedical cell products (BMCP), we wrote about the planned changes in…

Since the beginning of 2023, almost every month we have been updating the section dedicated to dietary supplements, namely…

At the beginning of October, Recommendation No. 26 “On guidelines for assessing the special significance of medicinal products…

The regulation on the interdepartmental commission to determine the list of scarce medical devices for their accelerated…

The Russian Ministry of Health and the expert center of the Federal State Budgetary Institution "SCEEMP" published an information…

At the VIII Eastern Economic Forum, held on September 10-13 in Vladivostok, an agreement was signed between the Center for…

In the summer of 2023, it became known about the purchase by Novo Nordisk of the Canadian company Inversago Pharma, which…

Compliance, adherence to treatment - the degree of correspondence between the patient’s behavior and the recommendations…

Every year in Moscow a scientific and practical conference RegLek is organized. This is a huge event aimed at covering many…

Often on the website of the State Register of Medicines (GRLS) messages appear for marketing authorization holders (MAHs)…

We are talking about the entry into force of amendments 9 and 10 of the edition of Decision 78 “On the Rules for Registration…

The Government of the Russian Federation published Resolution No. 1944 containing lists of cases in which the mandatory labeling…

According to Novo Nordisk's official website, the company is primarily engaged in the development and production of drugs…

The Ministry of Health of the Russian Federation has developed a draft of government decree (GD) on the procedure of circulation…

The well-known antibiotic amoxicillin has been found to have new undesirable effects. An information letter was published…

Eli Lilly, with the participation of biotechnology company Fauna Bio, will develop a new drug for the treatment of obesity.…

The press service of the Russian Ministry of Health announced the registration of the first BMCP - the Izitens product of…

Qnovia presented data from the first phase of studies of the effectiveness of the QN-01 device with the participation of…

Often in the specification of a regulatory document (ND) on quality you can find such a quality indicator as “Related substances”.…

The court ordered drug manufacturer Servier to pay 424 million euros for the sale of the drug Mediator (benfluorex), the…

With the entry into force of the EAEU Medicines Registration Rules, applicants have the opportunity to follow more flexible…

According to the results of a study by the Chinese company Refreshgene Therapeutics, as part of a clinical trial of AAV1-hOTOF…

In January 2024, the Russian Ministry of Health, together with the expert center of the Federal State Budgetary Institution…

Obtaining a registration certificate for a drug is by no means the last stage before entering the market, but rather one…

Johnson & Johnson has agreed to pay $700 million to settle claims related to the presence of carcinogenic talc in the company's…

The US Food and Drug Administration (FDA) has approved the first drug to combat severe frostbite. The drug Aurlumyn (iloprost)…

In mid-February, an order was published on the website of the State Register of Medicines (GRLS) to resume the use of the…

The US Food and Drug Administration (FDA) receives approximately 2 million reports of adverse drug reactions each year, each…

Registration certificate of a medicine is a document confirming the fact of state registration of a medicine.

Prime Minister Mikhail Mishustin instructed the Ministry of Education and Science to develop and put into operation the National…

Section 1.3.2 of Module 1 of the registration dossier for a medicinal product requires the provision of mock-ups and labeling…

Often in the composition of medicines and food products you can find a group of excipients such as azo dyes. Azo dye content…

In mid-May, the recommendations of the European Safety Committee (PRAC) on the suspension of registration certificates for…

The Drug Master File (DMF) is a document that contains detailed scientific information about the API, which is indicated…

Institute of Bioorganic Chemistry named after Shemyakina and Ovchinnikova (IBH), together with the Research computing Center…

Artificial intelligence (AI) opens up a wide range of opportunities for creating products for healthcare purposes. For example,…

Evidence—based medicine is an approach to medical practice in which decisions on the use of preventive, diagnostic and therapeutic…

Today, in the field of healthcare, doctors most often use evidence-based medicine approaches, which involve making decisions…

The term "digital twin" was first introduced to the general public in 2010 in the NASA Integrated Technology Roadmap for…

The final transition to the EAEU standards for medicines is planned for the end of 2025. By that time, the dossiers for all…

With the advent of the unified regulatory framework of the EAEU, significant changes have taken place in the classification…

According to the World Health Organization, schizophrenia is one of the 15 main causes of disability in the world. In specialized…

The potential of modern technologies and artificial intelligence is being evaluated in all sectors of the economy, including…

The scientific Journal of Agricultural and Food Chemistry published an article by a group of Danish scientists on the development…

Psychogenetics is an interdisciplinary field, in addition to psychology and genetics proper, which combines elements of neuroscience…

At the end of October 2024, information appeared on the GRLS website about amendments to consumer documentation for drugs…

Semaglutide is an analogue of the hormone GPP-1, which has several effects on the regulation of glucose concentration and…

During the phase III clinical trial, lenapacavir demonstrated 99% effectiveness in preventing HIV infection when used twice…

Currently, biohybrid, bionic and neurotechnologies are gaining popularity in the pharmaceutical industry. In this article,…

The U.S. Food and Drug Administration (FDA) has approved a drug for the treatment of progressive genetic heart disease –…

The Ministry of Health of the Russian Federation plans to amend Federal Law No. 61 to consolidate the concept of "list of…

The situation with the dossier harmonization with the requirements of the EAEU region in the pharmaceutical industry has…

For the first time in 20 years, a new non-dietary analgesic has entered the American market, which is able to block pain…

According to WHO, rectal cancer ranks eighth in the world in terms of prevalence. At the same time, the survival rate for…

The US FDA has approved a new antibiotic for the treatment of persistent intra-abdominal infections. The registered development…

The use of artificial intelligence (AI) in various areas of healthcare is gradually becoming routine practice. Medical institutions…

Several research centers have reported on the successful completion of the preclinical phase of cancer vaccine trials. The…

In a sense, the Russian pharmaceutical market in 2024 can be compared to a raging ocean. On the one hand, Russian pharmaceutical…

The American company Soleno Therapeutics has developed the first drug for the treatment of a rare hereditary disease, Prader-Willi…

AAU Soyuzpharma sent an appeal to Opora Rossii with a request to support the initiative to introduce reverse acceptance in…

Medical organizations that handle medicinal products for medical use, in accordance with Part 3 of Article 58_1 of the Federal…

Eisai and Biogen's Leqembi (lecanemab) was the first drug approved for the treatment Alzheimer's disease in Europe.

A GMP quality certificate is an official document confirming that the industrial facility itself and the medicinal products…

The website of the Unified Information System in the Sphere of Procurement reported that the St. Petersburg State Chemical-Pharmaceutical…

On July 22, 2025, the U.S. Secretary of Health signed a recommendation from the Centers for Disease Control and Prevention…

The first immunotherapy for recurrent respiratory papillomatosis in adults has been approved by the US Food and Drug Administration…

On January 1, 2025, the national project "New Technologies for Saving Health" was launched, which is aimed at developing…

Tirzepatide is a new drug developed for the treatment of obesity and type 2 diabetes.

In the United States, it has become possible to register medicines using an accelerated system, where applications from pharmaceutical…

The member states of the Eurasian Economic Union, hereinafter referred to as the member states, based on the Treaty on the…

"On Approving the Procedure for Submitting Information by a Legal Manufacturer of a Medical Device (its Authorized Representative)…

"On the List of Standards, through the Application of Which, on a Voluntary Basis, Full or Partial Compliance with the General…

From September 15 to September 22, the US Food and Drug Administration (FDA) approved three new drugs.

The search for the magic "anti-aging pill" has been going on for a long time. The dream of prolonging life and youth can…

Researchers at the University of Nottingham (UK), together with other researchers from the international community, presented…

An electronic tattoo is an electronic device that is attached to the skin's surface and transmits data remotely.It consists…

Technology is increasingly being integrated into various areas of human life, including medicine and pharmacy. So-called…

On December 29, the states of the Eurasian Economic Union signed a Protocol on amendments to the Agreement on Common Principles…

Has the procedure for bringing registration dossiers for medicines in line with the requirements of the EAEU (harmonization)…

In 2025, the European regulator registered 104 new drugs, which is an absolute record in the entire history of the agency.…

Medical devices with CGMS (Continuous Glucose Monitoring System) technology allow continuous monitoring of glucose in the…

The biotech company Insilico Medicine makes extensive use of artificial intelligence in the field of drug development.

Genome-wide association studies (GWA study, GWAS) is a field of biological (usually biomedical) research related to the study…

According to a press release from the UK's health regulator (MHRA), the package inserts for all glucagon-like peptide-1 (GLP-1)…

Generium has received marketing authorization for Efictel (INN: natalizumab). This is the first Russian analogue of Biogen's…