French manufacturers of veterinary medicines and their inspection
Konstantin Morozov, GMP Specialist, Auditor of Pharmaceutical Enterprises
This article provides information on French manufacturers of veterinary medicines and the French Agency for Veterinary Medicinal Products (ANMV).In addition, the articlesummarizes the results of an inspection of French manufacturers for compliance with the requirements of the Good Manufacturing Practice (GMP), which were conducted in 2017-2020 by specialists of the Federal State Budgetary Institution “The All-Russian State Center for Quality and Standardization of Veterinary Drugs and Feed” (FSBI “VGNKI”) subordinated to Rosselkhoznadzor.
French manufacturers of medicines for animals
According to the French Association for Animal Health Industry (SIMV), France is the European leader in research and manufacture of veterinary medicines and reagents, with over 6,700 employees, and the largest therapeutic arsenal in Europe (2,700 marketing authorizations). Furthermore, two in every three medicines produced in France are exported .
France offers products and services for the prevention and treatment of diseases affecting farm animals (cattle, pigs, sheep, poultry), pets (dogs, cats, horses), and wildlife (foxes, raccoons).
In addition, veterinary autogenous vaccines are produced in France. Autogenous vaccine is a vaccine prepared using microorganisms which have been isolated from the same infected animal to which it is then administered. Autogenous vaccines regulation is defined in the Public Health Code and in the Decree no. 2005-374 of 20 April 2005. Use of veterinary autogenous vaccines as an alternative approach can successfully control numerous bacterial infections and reduce the need for antibiotic treatment. French manufacturers are ready to share their experience in this area. [2, 3, 4].
Today, three French companies (Ceva Santé Animale, Virbac, Vetoquinol) are in the world’s top ten manufacturers of veterinary medicines.
In 1933, Joseph Frechin developed a medicinal animal antiseptic based on oxyquinoline double sulfate. The new medicine was named Vetoquinol. It was with him that the long history of a successful family business began, which has grown over time into a well-known international corporation. .
Today, with a direct presence in 24 countries, with 2500 employees and with almost 100 distributors, the company has built a global network which allows it to be close to its clients all over the world. It is present in three areas: anti-infectious agents, anti-inflammatory agents, cardiology-nephrology.
In the 1960s, the various preparations manufactured by human pharmaceutical laboratories at that time did not make it possible to treat all the animal diseases. In 1968, while major groups were looking to invest in animal health, Pierre-Richard Dick, a veterinary doctor in Nice, founded Virbac with a desire to provide veterinarians, farmers and pet owners worldwide with a set of innovative solutions to fight animal diseases. .
Now the company has 4,900 employees and is present in over 100 countries with 33 sales subsidiaries. Its product range is designed to cover the main pathologies in companion animals and livestock: parasiticides, antibiotics, vaccines, diagnostic tests, dog and cat nutrition, dermatology, dental hygiene, reproductive, aquaculture, anesthesia, geriatrics and electronic identification.
Ceva Santé Animale
Established in 1999, the international veterinary pharmaceutical company Ceva Santé Animale (Ceva) specializes in the research, development, production and marketing of pharmaceutical products and vaccines for livestock and poultry, and companion animals .
The company operates in 110 countries of the world and employs more than 5700 employees, has its own research and development centers and large manufacturing sites. Its activities cover 4 main directions in the production of veterinary medicines: biological products and vaccines, antibacterial medicines, reproduction control, regulation of the nervous system and control of animal behavior.
Also, in France, veterinary medicines are produced by such largest international manufacturers as, for example, Boehringer Ingelheim Animal Health, MSD Animal Health and Elanco Animal Health.
French agency for veterinary medicinal products (anmv)
The French Agency for Veterinary Medicinal Products (Agence Nationale du Médicament Vétérinaire, ANMV) monitors the quality of medicinal products for veterinary use distributed in France. In addition, ANMV issues marketing authorizations for the veterinary medicinal products, the licensing of pharmaceutical sites for the manufacturing, distribution and export. The agency is located near Fougères (Brittany region) and has 85 staff members, mainly specialized scientists.
History of the agency
The adoption in 1975 of the legislation on veterinary pharmacy prompted the French authorities to set up in Fougères a laboratory charged with evaluating marketing authorization application dossiers for veterinary medicinal products and with conducting research on the quality, efficacy and safety of those products. The Veterinary Medicines Laboratory ensured these two missions for 20 years. The numerous studies carried out on the toxicity and pharmacokinetics of residues enabled the laboratory to develop expertise in the area of protection of public health and to be nominated National Reference Laboratory for control of medicinal product residues in food in 1990, and in 1991 European Reference Laboratory in charge of residues of veterinary medicinal product with antimicrobial properties.
The rapid and regular increase in the workload and its specificity related to evaluation of marketing authorization applications for veterinary medicinal products, specifically resulting from implementation of the European Registration system for these products, made it necessary in 1994 to create the French Agency for Veterinary Medicinal Products. The ANMV was established alongside the Veterinary Medicines Laboratory.
The Agency has been in operation since 1995 and has rapidly developed its activities in all its areas of expertise. The ANMV was integrated into the French Food Safety Agency (AFSSA) in 1999, and has been a part of the National Agency for Food, Environmental and Occupational Health & Safety (Anses) since 2010 .
Structure of the agency
The director of ANMV (Jean-Pierre Orand) is appointed by joint order of the ministers responsible for agriculture and health, at the suggestion of the general director of Anses.
To fulfill the missions entrusted to it (antimicrobial resistance, European and international relations, regulatory and cross-functional issues), the Agency has three departments:
Scientific Assessment Department
This department is responsible, in particular, for the examination of veterinary medicinal products applications subject to authorization, registration or declaration, as well as for scientific projects. It is made up of two units.
The Expertise Unit responsible, in particular, for the expertise:
requests for the granting of marketing authorizations for veterinary medicinal products;
maximum residue limits;
scientific projects related to the department.
The Coordination Unit, responsible, in particular, for:
reporting on the dossier;
supervision of procedures;
planning and management of scientific projects related to the department;
coordination and spearheading of a mission focused on innovative treatment methods.
The Department of Administrative Decisions
This department is responsible, in particular, for validation, administrative review, preparation and monitoring of decisions concerning veterinary medicinal products and pharmaceutical sites, as well as certification.
The Department of Inspection, Surveillance and Pharmacovigilance
This department is responsible for compliance control and supervision of veterinary medicinal products on the market, pharmacovigilance and inspection of pharmaceutical sites, testing facilities and manufacturers of autogenous vaccines.
In particular, it provides:
inspecting and controlling establishments that manufacture, develop, import, distribute and export veterinary medicinal products, as well as establishments that manufacture autogenous vaccines, inspecting establishments in accordance with good practice applicable to these activities;
market surveillance and compliance control of veterinary medicinal products;
spearheading and coordination of the national veterinary pharmacovigilance system;
monitoring the balance of benefits and risks of medicinal products.
The Department includes:
The Inspection unit, responsible, in particular, for inspection and investigations related to establishments, testing facilities and products. This unit is headed by Grégory Verdier.
The Market Surveillance and Pharmacovigilance unit, in particular, for information, health monitoring, pharmaceutical monitoring (advertising, shortages…) and compliance control of veterinary medicinal products (quality defects…), as well as for the spearheading and coordination of the national veterinary pharmacovigilance system, in particular for the directing and following up the activities of the Veterinary Pharmacovigilance Centre in Lyon .
International activities of the agency
Thanks to its expertise, ANMV is an agency highly involved in European as well as international activities. In 2013, it obtained recognition for its expertise and management in this area through ISO 9001 certification, with both national and international scope. The Agency is certified to “provide international expert appraisal and developmental support in the area of veterinary medicinal product governance”.
Within Anses, the ANMV acts as the competent French authority in relation to the European Medicines Agency (ЕМА). It contributes actively to discussions on veterinary medicinal products and to the drafting of various regulatory and technical texts.
The Agency evaluates dossiers on veterinary medicinal products at the European level, carries out inspections in third countries on behalf EMA and is strongly committed to the project to revise EU veterinary medicinal product legislation. It is also involved in the system for monitoring antimicrobial resistance, and participates in discussions held by expert groups from the EMA and by other groups internationally. The Agency sits on the Board of the Med-Vet-Net Network of Excellence, which has the primary aim of developing and disseminating scientific knowledge on zoonoses.
The Agency works as a collaborating center for the World Organization for Animal Health (OIE) since 1995, and participates in work by the UN Food and Agriculture Organization (FAO), PIC/S and the WHO. It is heavily involved in programs concerning regulated diseases but also in those on emerging or re-emerging exotic diseases, and thus pools expertise with its European and international partners. As part of the OIE network, the ANMV is a leader in terms of research, expert appraisals, standardization, training and communication of applicable methodologies within its area of expertise .
Contacts with Russian competent authorities
In June 2019, a meeting of the Russian-French Working Group (CEFIC) on Agriculture was held in Paris. This event was attended by a representative of Rosselkhoznadzor. During the meeting, the parties discussed a wide range of issues related to cooperation between Russia and France in the field of veterinary supervision. In particular, they discussed scientific cooperation between ANMV and FSBI “VGNKI”. Taking into account the interest of both parties in the development of such cooperation, the parties agreed on the need to agree with the subsequent signing of a protocol agreement between FSBI “VGNKI” and ANMV .
In September 2019, the IV All Russia GMP Conference with international participation, organized by the Ministry of Industry and Trade of Russia together with the FSI “SID & GP”, was held in Svetlogorsk. As part of this Conference, a panel discussion and a round table for manufacturers of veterinary medicines were organized by the FSBI “VGNKI”.
Vincent Neuviale, inspector of manufacturers of veterinary medicines, provided information on the inspection for compliance with the GMP requirements conducted by ANMV in France and, in particular, highlighted the following points:
Programming and Planning: risk level-based approach (the frequency of site inspections depends on the number of points);
Preparation for inspection: notice for inspection, documentary study, on-site inspection agenda;
Carrying out the inspection: different types of inspection, viewed points;
Writing and sending initial report: templates for reports, contents (observations and GMP deficiencies);
Assessment of QP responses (including proposed corrective and preventive actions – CAPA) and conclusion (satisfactory, partially satisfactory, unsatisfactory);
Determination of the compliance status of the enterprise and joint decision of the inspectors.
He said that GMP inspections carried out in France can be divided into the following types:
Inspection target: system or product inspection;
Knowledge of inspectee: routine, concise or follow-up inspection (scope of inspection, number of days);
Subject of inspection: routine, quality systems review or special inspection;
Sponsor of inspection: inspection initiated by a national or European competent authority – The Committee for Medicinal Products for Veterinary Use (CVMP).
In ANMV, the classification of GMP deficiencies regarding to their significance is based on PIC/S and EMA documents: Critical, Major and Others. The most common deficiencies are associated with environmental monitoring, cleaning validation, redevelopment of manufacturing facilities.
In France, all manufacturers of medicinal products must have a GMP certificate issued by the regulator. If the enterprise does not meet the GMP requirements with the conditions for CAPA, then the GMP certificate is not issued or this certificate is issued with limitations .
Dialogue with an expert
ANMV Inspector Vincent Neuviale
ANMV Inspector Vincent Neuviale has kindly agreed to answer some of my questions regarding inspection issues.
Please tell me how many inspectors are there in your unit? How many inspectors are usually involved in an inspection? How many inspections are usually carried out in a year?
There are 6 inspectors in the inspection unit, head of unit included. All are veterinarians but in the past, some inspectors were pharmacists. We inspect manufacturers, distributors (French “exploitants”, i.e. MAH representative in France) and wholesalers of veterinary medicinal products (VMPs), Pharmacovigilance Head Quarters and Test facilities in France and manufacturers of VMPs in Third Countries. We check the compliance with GMP, GDP, GVP, GLP and soon GCP. For distributors and wholesalers, generally one inspector is needed. For manufacturers, it depends on the site size: 1 or 2 inspectors but more often 2. About 70 inspections are carried out per year, half of which are for manufacturers.
Does ANMV have an advanced training program for inspectors? Do agency inspectors participate in external training?
For new inspectors, there is an initial training: theoretical and practical with tutors (experienced inspectors). The training period could last up to one year. The new inspector has to be qualified in several domains with increasing complexity: distribution then non sterile production then sterile production and finally biologic production. Inspections are performed in pairs until the new inspector is qualified in each domain. Once qualified, a continuous training is in place: It is about 2 or 3 theoretical trainings per year per inspector that corresponds about minimum 5 days per inspector per year. Training is intern or extern according to the subjects and budget. Most of them are extern. Supervision inspections are performed regularly between inspectors to ensure that their requirements are the same and to maintain their qualification as inspector at ANMV. ANMV is also a PIC/S member and participate to the different seminar or training organized by PIC/S.
The COVID-19 pandemic has created restrictions that may affect and/or impede the conduct of on-site inspections. In this regard, the remote format of inspections is becoming more and more relevant. Does ANMV conduct inspections in this new format?
Due to the COVID-19 pandemic and travel restrictions, inspections were stopped for 3 months in 2020 (from March to May). During this lockdown, inspection team had worked on remote assessment SOP. Since June 2020, remote inspections have been put in place in addition to on-site inspections when it was possible. 18 remote inspections of distributors (“exploitants”) and manufacturers, pharmacovigilance Head Quarters were conducted until now. It is not the preferred format for manufacturers, considering that on-site inspections are more suitable.
Should French manufacturers inform ANMV about upcoming Russian inspections, about the results of these inspections? Is there any monitoring of deficiencies identified during Russian inspections?
Some French manufacturers inform AMNV about upcoming Russian Inspections. Once ANMV informed and if the French manufacturer wishes it, a French inspector can assist to the Russian inspection as an observer. Russia may inform both the French Ministry of Agriculture and the Ministry of Foreign Affairs about the different deficiencies observed by Russian inspectors and if any, this information is transmitted to ANMV. If deficiencies observed by Russian inspectors concern requirements also present in the EU cGMP, those deficiencies could be monitored during a future inspection of the site by ANMV.
In Russia, the European practice of using autogenous vaccines is of growing interest. As far as I know, ANMV is planning to take part the Autogenous Vaccines Meeting “Quality of Production and Movement in a Common Market” (Munich, September 2021). Does the agency expect specific GMP Rules for autogenous vaccines to be developed and adopted in the future?
Autogenous vaccines are important in France specially for minor species like fish, we use more than 160 million of doses per year. We have a great experience of such products. Annex 1 and Annex 5 of the EU cGMP guide are not very suitable to autogenous vaccines. In France, since 2008 there has been a specific good manufacturing guide for autogenous vaccines. The new Vet Regulation expects GMP guide for autogenous vaccines at EU level. ANMV wishes to participate and share its knowledge and experience to the future EU drafting group on this topic.
In 2019, you participated in the All Russia GMP Conference. Did you enjoy this event? If you were invited to Russia to one of the following conferences, would you take part in this?
Yes, it was a great experience: the possibility to exchange with inspectors from others countries (inside EU and from Third Countries) and better understand the requirements of the Russian authorities. For the following conferences, I think the director of the agency or the head of the inspection unit may assist to them if available and if the presentation of a subject is asked.
Russian GMP inspections of French manufacturers of veterinary medicines
Russian inspectors began to conduct GMP inspections of foreign manufacturers of medicinal products for veterinary use in June 2017, and the first inspections of French manufacturing sites took place in September 2017.
According to the register of issued conclusions published on the Rosselkhoznadzor website 18.03.2021 , in 2017-2020 the largest number of conclusions (20%) was made by Rosselkhoznadzor in relation to manufacturers from France. During this time, 21 inspections were conducted at manufacturing sites located in 9 out of 13 French regions.
To date, the number of refusals to issue GMP conclusions to French sites is still high, however, by January 2021 they received they have already received six positive conclusions. The results may indicate that these veterinary medicines manufacturers have begun to better prepare for inspections.
For 2021, six Russian GMP inspections of manufacturing sites located in France are already planned (including follow-up inspections). French manufacturers openly share their experience in passing inspections .
The attractiveness of France in matters of animal health lies in its scientific and technical expertise, manufacturing capacities and high-quality products.On the other hand, the Russian market is also attractive for French manufacturers of medicinal products for veterinary use. Proper preparation to Russian GMP inspections is very important for all manufacturers.The experience of the French Agency for Veterinary Medicinal Products may also be of interest to Russian inspectors.
The National Agency for Food, Environmental and Occupational Health & Safety (Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, Anses) is a French agency who undertakes monitoring, expert assessment, research and reference activities in a broad range of topics that encompass human, animal and plant health
The European Medicines Agency (EMA) is an agency of the European Union in charge of the evaluation and supervision of medicinal products
The World Organization for Animal Health (Organisation Mondiale de la Santé Animale), formerly the Office International des Epizooties (OIE) is an intergovernmental organization coordinating, supporting and promoting animal disease control
The Food and Agriculture Organization of the United Nations (FAO) is a specialized agency of the United Nations that leads international efforts to defeat hunger and improve nutrition and food security
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of GMP of medicinal products for human or veterinary use.
The Committee for Medicinal Products for Veterinary Use (CVMP) is the EMA’s committee responsible for elaborating the opinions on all questions concerning veterinary medicines
The Russian-French Council on Economic, Financial, Industrial and Trade Issues (Conseil économique, financier et commercial, CEFIC) is the main working structure of the Russian-French Commission on Bilateral Cooperation at the level of heads of government
The Federal State Budgetary Institution “The All-Russian State Center for Quality and Standardization of Veterinary Drugs and Feed” (FSBI “VGNKI”) is an institution authorized to conduct inspections of manufacturers of veterinary medicinal products manufactured outside the Russian Federation for compliance with the GMP rules requirements
The Federal State Institution “State Institute of Drugs and Good Practices” (FSI “SID & GP”) is an institution authorized to conduct inspections of manufacturers of medicinal products for human use manufactured outside the Russian Federation for compliance with the GMP rules requirements
ISPE announced the release of its latest Guide, ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry. The Guide focuses on how Knowledge Management (KM) can enable a more effective Pharmaceutical Quality System (PQS).
An efficacy study was conducted in Bahrain in accordance with WHO guidelines involving more than 5,000 subjects. Overall efficacy beyond 14 days after administering the second dose was estimated at 94.3%.
Sanofi and GSK started enrollment in their Phase 3 clinical study to assess the safety, efficacy, and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate. The global, randomized, double-blind placebo-controlled Phase 3 study will include more than 35,000 volunteers aged 18 and older from several countries, including sites in the US, Asia, Africa, and Latin America. The primary endpoint of the study is the prevention of symptomatic COVID-19 in SARS-CoV-2 naïve adults, with secondary endpoints being the prevention of severe COVID-19 disease and prevention of asymptomatic infection. In a two-stage approach, the study will initially investigate the efficacy of a vaccine formulation targeting the original D.614 virus (Wuhan), while a second stage will evaluate a second formulation targeting the B.1.351 (South African) variant. Recent scientific evidence1 shows that antibodies created against the B.1.351 variant may provide broad cross-protection against other more transmissible variants. The design of the Phase 3, conducted across a broad diversity of geographies, also allows evaluation of the efficacy of the candidate against a variety of circulating variants. Following encouraging interim results from the recent Phase 2 study, the companies will also begin clinical studies in the coming weeks to assess the ability of the adjuvanted recombinant-protein […]
Russian pharmaceutical company NovaMedica (part of the RUSNANO portfolio) and the corporation Bayer signed an agreement to provide Bayer with an exclusive license to commercialization of an innovative product developed by NovaMedica, including its manufacturing and promotion. The product in question is used for the treatment of proctologic diseases and has been developed as part of NovaMedica’s own R&D program. Bayer intends to commercialize it under the trade name Reliefipin. The product is a combination of two active ingredients with a therapeutic and pain relieving effect and will be manufactured in the form of topical water-based gel, which ensures effectiveness and convenience in the treatment of such diseases. In developing the product, NovaMedica used technologies that allowed combining previously incompatible active ingredients in one form, while improving their physical and chemical properties manifold. The formulation is patent-protected. Reliefipin will be available at Russian pharmacies as early as this June. The parties do not disclose financial details of the deal. Elena Litvinova, CEO, NovaMedica: “We are building our R&D program with a view to find out-of-the-box solutions to meet the current needs of patients. This is our focus. The fact that Bayer showed interest in our product means recognition of NovaMedica’s […]
Bayer is building a new pharmaceutical facility in Turku and at the same time modernizing its existing production plant. The new production facility will use the latest technology and utilize automation and robotics extensively. The value of the total investment is €250 million, which is one of the largest investments in Finland in recent years. The investment will further strengthen Bayer’s footprint in Finland and Turku’s position as the contraceptive capital of the world. This investment is significant for both Bayer and Finland. It secures long-term supply, which is required to meet Bayer’s global sustainability goals. One of these goals is to provide 100 million women in low-and middle-income countries with access to family planning and modern contraception by the end of 2030. Turku plays a significant role in Bayer’s global sustainability strategy which is in line with the UN Sustainable Development Goals. The investment will further promote the measures that our Turku plant has already taken over the past 30 years, to achieve gender equality and support women and their families. This way we can make an impact on women’s health and social status, education and family size, – says Miriam Holstein, CEO of Bayer Nordic Bayer’s global sustainability […]
American Gene Technologies (AGT), a clinical-stage biotechnology company, announced treatment of the first participant in its Phase I clinical trial to evaluate safety of the cell and gene therapy product AGT103-T. Designated as the RePAIR trial (Restore Potent Antiviral Immune Responses, NCT04561258), participants are infused once with their own CD4 T cells that were enriched, for cells capable of reacting to HIV, and genetically modified to resist infection. The first infusion took place at Washington Health Institute, Washington, D.C. on May 19. This is a first-in-human study for AGT103-T. The primary endpoint is safety; testing related to secondary endpoints evaluates responses to treatment including changes in the immune response to HIV. Participants treated with AGT103-T will be followed for 6 months in this safety study before enrolling in an FDA-mandated 15-year long-term follow up required for all gene therapy trials. Enrollment, product manufacturing, and treatments are ongoing at AGT’s clinical trial sites. “Treating the first person with our product is an important step forward and the culmination of design, development, manufacturing, and approval of the product for human testing. We believe this therapy is capable of changing the body’s ability to fight HIV and the first-in-man study signals the first […]
Etten-Leur, Tokyo, Moscow, June 9, 2021. R-Pharm Group announces the signing of a distribution agreement with PHC Europe B.V., one of the largest suppliers of biopharmaceutical and medical equipment, formerly known as Panasonic Biomedical Sales Europe B.V.. The agreement provides for R-Pharm to register and promote in Russia, Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Uzbekistan and Ukraine its high-tech refrigeration equipment, biotech incubators, climate chambers and an entire line of equipment for laboratories, biotech facilities, and medical institutions. PHCbi refrigeration equipment covers a temperature range from +23 to -150 ℃, making it possible to store all known types of vaccines and biologics, as well as blood and its components. It is important to note that the PHC refrigeration equipment is designed not only for medical institutions, but also for research laboratories and biopharmaceutical production. As of today, R-Pharm’s production sites have already purchased more than 20 units of equipment to support the vaccine project. Denis Cherednichenko, Vice-President for Medical Systems at R-Pharm Group: We welcome the agreement between R-Pharm and PHC Europe B.V. coming into force. It represents an important milestone in the development of the strategic partnership between Russia and Japan. Regarding the organization of this cooperation, […]
A Wuhan-based affiliate of China National Pharmaceutical Group (Sinopharm) said the start of operations at a new factory will raise the annual production capacity of its COVID-19 vaccine to at least 1 billion doses.
The minister also revealed that the Karaganda pharmaceutical plant will produce extra 1,7 million doses of Sputnik V vaccine. They will be distributed among regions of the country according to the approved schedule.
When an epidemic of smallpox came to the English village of Yetminster in 1774, Benjamin Jesty vaccinated his family with cowpox, and later Peter Plett repeated this experiment. The first known vaccines were developed in 1796, when Edward Jenner after finding a case of cowpox in a dairy maid collected matter from her pustules and inoculated an 8-year-old boy. In the 1870-80s, Louis Pasteur developed the first vaccines for anthrax and rabies. Autogenous vaccine (prepared from the bacteria harbored by the patient) was first introduced by Sir Almroth Edward Wright in 1903. In the following years, several case reports were published regarding the preparation and indications of autogenous vaccines. This article is dedicated to veterinary autogenous vaccines used to treat various animal infections. Important role of veterinary autogenous vaccines Today, autogenous vaccines play a much more important role than simply “filling the gap” where there are no commercial products currently available. They play a vital role in preventative health management programs, allowing veterinarians to stay close to the farm, better understand the existing disease status and as a result reduce the need for emergency treatments. This is particularly vital to ensure that antibiotics remain effective and available for use when […]
The European Medicines Agency (EMA) announced on June 11, 2021 that its committee for human medicines (CHMP) has approved a new manufacturing site for the production of Moderna COVID-19 vaccine finished product. The site, operated by Recipharm, is located in Monts, France. In addition to the new manufacturing facility for this vaccine, the CHMP has also given a positive opinion for the addition of several alternative sites responsible for batch control/testing. Already on 4 June 2021, two new sites for the manufacturing of active substance and finished product intermediates, located in the US (ModernaTX, Inc., Norwood, Massachusetts and Lonza Biologics, Inc., Portsmouth, New Hampshire), were approved by CHMP. Together, these changes are expected to allow the production of an additional one to two million vials of ready-to-use vaccine for the European Union market every month. This will increase the supply of the vaccine in the European Union. This recommendation does not require a European Commission decision and the site in Monts can become operational immediately. The changes described will be included in the publicly available information on this vaccine.
Presidential Decree UP-No. 6221 of 5 May 2021 has introduced a registration recognition procedure for medical devices from June 1, 2021. Medical devices that have been registered with the following foreign organizations shall be subject to the recognition procedure: Food and Drug Administration (FDA), USA. Bodies authorized to issue the European Certificate of Conformity (CE), European Union. European Medicines Agency (EMA), European Union. Pharmaceuticals and Medical Devices Agency (PMDA), Japan. Ministry of Food and Drug Safety (MFDS), Republic of Korea. Medicine and Healthcare Products Regulatory Agency (MHRA), United Kingdom. Medical devices certified under the requirements of the above organizations during the state registration in the Republic of Uzbekistan, shall not be tested in vitro and shall be duly registered no later than fifteen working days. Also, the State Customs Committee (Azimov M. B.), together with the Pharmaceutics Development Agency, the Uzstandard Agency, the Commissioner for the Protection of the Rights and Legitimate Interests of Business Entities and the Chamber of Commerce and Industry, shall establish permanent control over the import of medical devices and their components provided for in this paragraph, without allowing unnecessary barriers.
EMA’s safety committee (PRAC) has concluded that people who have previously had capillary leak syndrome must not be vaccinated with Vaxzevria (formerly COVID-19 Vaccine AstraZeneca). The Committee also concluded that capillary leak syndrome should be added to the product information as a new side effect of the vaccine, together with a warning to raise awareness among healthcare professionals and patients of this risk. The Committee carried out an in-depth review of 6 cases of capillary leak syndrome in people who had received Vaxzevria.1 Most of the cases occurred in women and within 4 days of vaccination. Three of those affected had a history of capillary leak syndrome and one of them subsequently died. As of 27 May 2021, more than 78 million doses of Vaxzevria had been administered in the EU/EEA and the UK.2 Healthcare professionals should be aware of the signs and symptoms of capillary leak syndrome and of its risk of recurrence in people who have previously been diagnosed with the condition. People who have been vaccinated with Vaxzevria should seek immediate medical assistance if they experience rapid swelling of the arms and legs or sudden weight gain in the days following vaccination. These symptoms are often associated […]
Young scientists from NUST MISIS have presented multilayer antibacterial coatings with a prolonged effect and a universal spectrum of action. The coating is based on modified titanium oxide and several antiseptic components. The coatings can be used in modern implantology as a protective layer for the prevention of concomitant complications – inflammation or implant rejection. The results of the work have been published in the international scientific journal Applied Surface Science. Antibacterial coatings are currently being actively researched, as the search for alternatives to traditional antibiotics is growing. They can be applied to implants, thereby preventing inflammation caused by nosocomial infections. Nevertheless, the creation of antibacterial, but at the same time biocompatible and bioactive surfaces is a problem that the scientific community has been solving for many years, and the “dream materials” have not been developed. Young scientists from the NUST MISIS Laboratory of Inorganic Nanomaterials have created an innovative multilayer coating that synthesizes the protective properties of nanoparticles, biopolymers, anticoagulants and antibiotics. The antibiotic and silver nanoparticles provide an antibacterial effect, while heparin prevents bacterial cells from sticking to the tissue surface, which reduces the amount of antibacterial agent required. The method of obtaining a multilayer coating is a […]
Scientists claim the nanoparticles obtained can carry an increased antibiotic “load” and easily penetrate tissues from the bloodstream and back, ensuring continuous drug delivery to the site of infection.
Russia should minimize its dependence on imports of ready-made medicines and pharmaceutical substances, Russian Deputy Prime Minister Tatyana Golikova said on Thursday. /TASS/ “In 2020, we updated the list of drugs strategically important for the country, the production of which should be in a full cycle [created within Russia — TASS]<…> The pace [of production] is important here. Of course, the production of cardiovascular and oncological drugs means long cycles of preclinical and clinical trials, but our work with vaccines has shown that we know how we can, and so we must. We must minimize our country’s dependence on imports <…> both on foreign pharmaceutical substances and on ready-made medicines,” she said at the final board of the Industry and Trade Ministry. Golikova recalled that in 2020, the government updated the list of 215 strategically important drugs, the production of which should be fully located in the country. By 2024-2025, a full production cycle in Russia should be provided for 65% of such drugs, by 2030 — for 80%, the Deputy Prime Minister emphasized. “These are mainly painkillers, cardiovascular and oncological drugs <…>”, Golikova specified.
It is envisaged to implement the project in three stages from 2021 to 2024, the amount of investment from the company “SOLYPHAR” will be more than 20 million US dollars, in accordance to the international GMP standards.
This Combination Vaccine May Simplify Execution and Reduce Shots Needed to Complete CDC’s Recommended Child and Adolescent Immunization Schedule VAXELIS™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine), developed as part of a U.S.-based partnership between Merck, known as MSD outside the United States and Canada, and Sanofi Pasteur, the global vaccines business unit of Sanofi, is now available in the U.S. VAXELIS is the first and only hexavalent (six-in-one) combination vaccine available in the U.S. indicated for active immunization to help prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday). Given the potential to reduce the number of shots by as many as three in the first six months of life, as compared to pentavalent vaccines plus hepatitis B or Haemophilus influenzae type b vaccines, VAXELIS represents an important option for healthcare professionals and parents, – said Joanne Monahan, senior vice president, U.S. Vaccines, Merck. – Merck and Sanofi have been in contact with the major insurers and the appropriate pricing […]
The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) and Panacea Biotec, one of the leading vaccine and pharmaceutical producers in India, today announced the launch of production of the Russian Sputnik V vaccine against coronavirus. The first batch produced at Panacea Biotec’s facilities at Baddi will be shipped to the Gamaleya Center for quality control. Full-scale production of the vaccine is due to start this summer. Company’s facilities comply with GMP standards and are prequalified by WHO. Sputnik V was registered in India under the emergency use authorization procedure on April 12, 2021 and vaccination against coronavirus with the Russian vaccine started on May 14. As announced in April, RDIF and Panacea have agreed to produce 100 million doses per year of Sputnik V. To date Sputnik V has been registered in 66 countries globally with total population of over 3.2 billion people. Efficacy of Sputnik V is 97.6% based on the analysis of data on coronavirus infection rate among those in Russia vaccinated with both components of Sputnik V from December 5, 2020 to March 31, 2021. The vaccine is based on a proven and well-studied platform of human adenoviral vectors and uses two different vectors for […]
Human Vaccine LLC, a wholly owned subsidiary of the Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) announces the signing of an agreement for the supply of 220 million doses of two-dose Sputnik V Russian COVID-19 vaccine with the United Nations International Children’s Emergency Fund (UNICEF). This amount is sufficient to vaccinate 110 million people. The supply agreement with UNICEF for Sputnik V vaccine will broaden access to help meet vaccine demand around the world. Procurement and delivery of the vaccine by UNICEF is subject to the vaccine receiving WHO Emergency Use Listing. The decision is expected soon on the Sputnik V application for WHO Emergency Use Listing that was submitted in October 2020. Concurrently, RDIF will be holding a separate discussion with Gavi, the Vaccine Alliance to see the Sputnik V vaccine considered for inclusion in the COVAX Facility’s Portfolio of COVID-19 vaccines. The COVAX Facility (co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO) together with UNICEF aims to help end the acute phase of the global pandemic by the end of 2021 by providing rapid, fair and equitable access to safe and effective vaccines to all participating countries and territories regardless of income level, thus enabling […]
The U.S. Food and Drug Administration has approved Pfizer Inc.’s (PFE) PREVNAR 20 or Pneumococcal 20-valent Conjugate Vaccine for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae or pneumococcus serotypes in the vaccine in adults ages 18 years and older.
The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) and Sanofi, one of the leading global pharmaceutical companies, agree to cooperate for joint implementation of digital healthcare projects in Russia. The corresponding announcement was made on June 4 on the sidelines of St. Petersburg International Economic Forum. Sanofi and RDIF are planning to engage in development, maintenance, management and commercialization of Virtual Healthcare products in Russia in four therapeutic areas, including hypertension and diabetes. The products include a range of Sanofi’s initiatives, such as combination of drug therapy and technology, standalone digital therapeutics and tech-enabled virtual healthcare (virtual clinics, telehealth and wearables). The agreement is part of RDIF’s strategy of promoting the leading healthcare technologies in Russia within the framework of RDIF.Healthcare division aiming to develop existing initiatives and launching new investment projects. Thanks to wide international network of partners and accumulated internal expertise, RDIF is implementing a number of leading anti-COVID projects in Russia and globally and is now joining efforts with Sanofi to develop new cutting-edge healthcare solutions in the future.
This article provides information on French manufacturers of veterinary medicines and the French Agency for Veterinary Medicinal Products (ANMV). In addition, the article summarizes the results of an inspection of French manufacturers for compliance with the requirements of the Good Manufacturing Practice (GMP), which were conducted in 2017-2020 by specialists of the Federal State Budgetary Institution “The All-Russian State Center for Quality and Standardization of Veterinary Drugs and Feed” (FSBI “VGNKI”) subordinated to Rosselkhoznadzor. French manufacturers of medicines for animals According to the French Association for Animal Health Industry (SIMV), France is the European leader in research and manufacture of veterinary medicines and reagents, with over 6,700 employees, and the largest therapeutic arsenal in Europe (2,700 marketing authorizations). Furthermore, two in every three medicines produced in France are exported . France offers products and services for the prevention and treatment of diseases affecting farm animals (cattle, pigs, sheep, poultry), pets (dogs, cats, horses), and wildlife (foxes, raccoons). In addition, veterinary autogenous vaccines are produced in France. Autogenous vaccine is a vaccine prepared using microorganisms which have been isolated from the same infected animal to which it is then administered. Autogenous vaccines regulation is defined in the Public Health Code and […]
The Russian Health Ministry has issued a permit to conduct the post-registration clinical trials of the CoviVac shot against the coronavirus infection with the participation of 32,000 volunteers. The corresponding information was published on the website of the state register of clinical trial permits of the Russian Health Ministry on Tuesday. (TASS) “An open comparative study of the preventive efficacy and a non-comparative study of the immunogenicity and safety of the CoviVac preparation (a whole-virion inactivated concentrated purified coronavirus vaccine), produced by the Federal State Budgetary Scientific Institution Chumakov Federal Scientific Center for Research and Development of Immune and Biological Products of the Russian Academy of Sciences on healthy volunteers aged 18-60. The beginning of the trials kicked off on June 2, 2021, and will end on December 30, 2022. The number of patients amounts to 32,000,” – according to the information posted on the website. The register also indicates that the trials will be held on the basis of 16 medical organizations in Kirov, St. Petersburg, Moscow, Obninsk, Chelyabinsk, Tatarstan, Zheleznogorsk, Stary Oskol, and Novotroitsk. On February 19, the Russian Healthcare Ministry certified the whole-virion inactivated CoviVac vaccine, developed by the Chumakov Federal Scientific Center for Research and Development […]
Isotope JSC (a part of Rusatom Healthcare JSC, Rosatom’s radiation technologies integrator) has signed a five-year contract with Brazil’s Nuclear and Energy Research Institute (IPEN; linked to the National Nuclear Energy Commission or CNEN) to supply lutetium-177 and actinium-225, the most promising medical isotopes in radiopharma. A long-term contract for monthly supplies of 177Lu-trichloride carrier-added became possible following a successful registration of lutetium-177 manufactured by INM JSC and approval of the Russian-made radioisotope for further registration of radiopharmaceutical DOT-IPEN-177 produced by IPEN/CNEN by the Brazilian National Health Surveillance Agency (Anvisa). The contract strengthens ROSATOM’s standing as the leading supplier of radioisotopes to the Latin American markets. This contract is the result of many years of meticulous work on both sides. It is of great social importance as it opens up new possibilities for the treatment of thousands of patients. With its unique technological base of research reactors, ROSATOM State Corporation produces the widest range of medical isotopes. One of the key tasks of Rusatom Healthcare and Isotope JSC is to increase the availability of radionuclide products which are the foundation of Nuclear Medicine. Collaboration with IPEN-CNEN is an example of international cooperation aimed to introduce high technologies to cancer treatment […]