Transition of Veterinary Manufacturers to the EAEU GMP Rules
In October 2020, the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) announced that from January 1, 2021, the Rules of Good Manufacturing Practice of the Eurasian Economic Union, approved by the Resolution of the Council of the Eurasian Economic Commission of November 3, 2016 No. 77, will come into force, in relation to medicinal products for veterinary use. Compliance with these Rules will be taken into account when issuing permits (licenses) to manufacturers of medicinal products for animals for these activities, as well as when inspecting them . In this short overview, we’ll look at some of the articles, presentations and documents that veterinary manufacturers may find useful.
The text of the Rules of Good Manufacturing Practice of the Eurasian Economic Union (the EAEU GMP Rules) is published on the website of the Eurasian Economic Commission (EEC) in the section “Resolutions of the Council of the Eurasian Economic Commission” . The EAEU GMP rules were approved in 2016. They entered into force in 2017, with the exception of the provisions of these Rules concerning the requirements for the production of veterinary medicinal products.
The requirements of the EAEU GMP Rules for the manufacture of veterinary medicinal products are the same as for the manufacture of medicinal products for human use. Special requirements of these Rules for veterinary medicinal products and immunobiological veterinary medicinal products are set out in the Annexes No. 4 and 5. Part II of the EAEU GMP was developed based on the ICH guidelines published as an ICH Q7A document for active pharmaceutical ingredients. This part applies both to medicinal products for human use and veterinary medicinal products.
According to Dmitry Rozhdestvensky, Head of the Division for Coordination of Common Market for Drugs and Medical Devices Formation, Technical Regulation and Accreditation Department of the EEC and Andrey Meshkovsky, associate Professor of the Department of organization of production and sale of medicines of the Sechenov First Moscow State Medical University, authors of the article “On the Application of GMP Rules in the EAEU Member States” published on the GMP News internet portal in February 2020, a comparison of the texts of the EAEU GMP Rules and the Rules of Good Manufacturing Practice approved by the Order of the Ministry of Industry and Trade of Russia dated June 14, 2013 No. 916 (the GMP Rules of the RF)  does not reveal fundamentally important discrepancies between them .
On the website of the Federal State Institution “State Institute of Drugs and Good Practices” (FSI “SID & GP”) subordinated to the Ministry of Industry and Trade of Russia, in the section “Inspection” there is a presentation “Main differences between the GMP Rules of the RF, the EAEU GMP Rules and the EU GMP Rules (Information note)” . This presentation covers the main differences between the GMP Rules of the RF and the EAEU GMP Rules, as well as an overview of changes in the EU GMP Rules: Volume 4 of “The Rules Governing Medicinal Products in the European Union” .
In August 2020, an article by the GMP expert of IBA Elena Zelinskaya and the QC Head of JSC “Tatchempharmpreparaty”, Elena Sadykova, entitled “Comparison and Analysis of the GMP Requirements of the Russian Federation and the EAEU” was published on the GMP News internet portal . Both the GMP Rules of the RF and the GMP Rules of the EAEU are a translation of the EU GMP Rules. However, they also have differences. The EAEU GMP Rules are closer in structure and translation accuracy to the original. They also include Part III “GMP related documents”. The GMP rules of the RF were developed in 2013, and the last amendments to Part I of the EU GMP Rules were introduced in 2015, accordingly, the EAEU GMP Rules included these changes. The authors of this article set out to compare Part I of both documents and presented a comparative table.
Interesting discrepancies in the text of the GMP Rules are found by the Head of the Validation Department of LLC “LabPromEngineering” Alexander Belinsky in the article “Regulatory quests and labyrinths, or who lives well in Russia: an old fairy tale in a new way with a pharma accent” which was published on the PharmaPharm internet portal in 2019. For example, he draws attention to some differences between the paragraphs of Chapter 3 “Premises and equipment” and Annex No. 4 regarding veterinary medicinal products, in the context of dedicated and self-contained facilities .
It is important to understand that the EAEU GMP Rules, like the EU GMP Rules, will be regularly reviewed to reflect the continuous improvement of quality management practices. This applies to both the Rules themselves and their Annexes. The purpose of regulating the EAEU GMP Rules is to establish uniform approaches and eliminate differences in the requirements of the pharmaceutical inspectorates of the Eurasian Economic Union Member States when conducting pharmaceutical inspection and confirming the stability of the quality of products.
In June 2020, an article titled “The EAEU will establish uniform requirements for qualification and validation in pharmaceutical production” was published on the GMP News internet portal . This article describes the proposed changes to Annex 15 to the EAEU GMP Rules “Requirements for qualification and validation”, including: introduction of terms such as “User Requirements Specification (URS)”, “Factory Acceptance Testing (FAT)”, “Site Acceptance Testing (SAT)”; introduction of new approaches to process validation, including continuous process verification, hybrid approach, ongoing process verification during lifecycle, justified application of the bracketing approach for new products; new sections related to verification of transportation, validation of packaging; establishment of limits for the carryover of product residues during cleaning validation based on a toxicological evaluation, etc. Among the most important proposed changes – retrospective validation is no longer considered an acceptable approach.
The text of the draft updated version of Annex 15 has already been preliminarily agreed upon at the level of EAEU expert groups and published on the EEC website in the section “Projects of the working group on the formation of common approaches to the regulation of drug circulation within the Eurasian Economic Union” . At present, the final approval of the draft document is expected.
At the current moment, the EAEU GMP Rules contain Annex 16 which is based on the translation of Annex 16 to the EU GMP Rules, published in 2001 and entered into force in 2002. In 2015, Annex 16 to the EU GMP Rules was revised and its updated version entered into force in 2016.
A presentation by Vladimir Orlov, who is currently the Director of the International Society for Pharmaceutical Engineering of the Eurasian Economic Union – Eurasian ISPE Affiliate, is posted on the website of FSI “SID & GP” in the section “Inspection” on the topic “Overview of the main innovations in the new version of Annex 16 to GMP rules – “Requirements for confirmation by a Qualified person of compliance of a product batch for release” . This presentation covers the requirements of the regulatory framework of the Russian Federation and the European Union, the new version of Annex 16 to the EU GMP Rules and some key changes in the content of the updated version of Annex 16 on the example of a draft translation of the specified document for the EAEU GMP Rules.
On September 30, within the framework of the V All-Russia GMP Conference with international participation held online, a round table “Current trends in global legislation and global harmonization” was held. At this round table, Tatiana Vyazmina, the Quality Director of R-Pharm Group, made a presentation on the topic “General provisions of the new version of the draft Annex 16 of the EAEU GMP from the perspective of the GMP requirements and the Qualified person at pharmaceutical enterprise” . She provided some comparisons of the current version and the draft of the new version of Annex 16. In particular, the project involves the introduction / correction of terms and definitions (“Batch certification”, “Marketing authorization holder”, “Certification of compliance for individual stages of drug product manufacturing process”); the provision that the key responsibility for safety, quality and efficacy of a medicinal product rests with MAH throughout the whole product lifecycle; the provision that the evidence of certification for a batch of medicinal product is documented by QP in a register or in a similar document intended for this purpose, etc.
In October 2020, on the Federal Portal of Draft Normative Legal Acts, the draft “On amendments to the Order of Rosselkhoznadzor No. 755 of October 18, 2016 “On approval of the application form related to determination on manufacturer (foreign manufacturer) of medicinal products for veterinary use compliance with the requirements of the Rules of Good Manufacturing Practice, the form of an inspection report on the results of inspection of manufacturer (foreign manufacturer) of medicinal products for veterinary use with respect to its compliance with the requirements of the Rules of Good Manufacturing Practice, and the form of conclusion on the compliance of the manufacturer (foreign manufacturer) of medicinal products for veterinary use with the requirements of the Rules of Good Manufacturing Practice ” was posted .
The text of the normative legal act, finalized following the results of public discussions, includes the following changes:
In the form of an inspection report on the results of inspection of manufacturer (foreign manufacturer) of medicinal products for veterinary use with respect to its compliance with the requirements of the Rules of Good Manufacturing Practice, approved by the Order, footnote <2> shall be stated as follows: “<2> All identified nonconformities are assessed in accordance with the requirements of the Rules of Good Manufacturing Practice of the Eurasian Economic Union approved by the Resolution of the Council of the Eurasian Economic Commission of November 3, 2016 No. 77 (official website of the Eurasian Economic Union, November 21, 2016)”, with references to the clauses of the act constituting the law of the Eurasian Economic Union;
In the form of conclusion on the compliance of the manufacturer (foreign manufacturer) of medicinal products for veterinary use with the requirements of the Rules of Good Manufacturing Practice, approved by the Order, the words “the Rules of Good Manufacturing Practice approved by the Order of the Ministry of Industry and Trade of Russia dated June 14, 2013 No. 916” shall be replaced by the words “the Rules of Good Manufacturing Practice of the Eurasian Economic Union approved by the Resolution of the Council of the Eurasian Economic Commission of November 3, 2016 No. 77 (official website of the Eurasian Economic Union http://www.eaeunion.org/, November 21, 2016)”; after the words “the Rules of Good Manufacturing Practice” add the words “Eurasian Economic Union”;
This order comes into force on January 1, 2021.
On October 8-9, 2020, on the basis 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, a training seminar was held. In the training program, the specialists of the FSBI “VGNKI” paid special attention to a comparative review of the EAEU GMP Rules and the GMP Rules of the RF .
To be continued
What other events and activities planned for the already ending 2020 can be recommended to manufacturers of veterinary medicinal products?
The “PHARMSTRATEGY” company and FSI “SID & GP”, within the joint program of promoting implementation of the best practices in the Russian pharmaceutical industry, have come up with the initiative of the “SOLIDARY TRAINING PROGRAM” project. Since September 2020, they have been hosting corporate webinars for companies with an “open-door policy”. At the same time, the company for which the event is held provides all interested employees of the industry with the opportunity to take part in it free of charge, thus showing industry solidarity and contributing to the achievement of common and not exclusively internal corporate interests. One of the prerequisites for the project is the introduction of Eurasian GMP standards and preparation for the start of inspection of Russian enterprises for compliance with the requirements of the EAEU GMP Rules .
On December 16, 2020, the Eurasian ISPE Affiliate will hold an online preconference, within which international experts and regulators of the Eurasian market will discuss the specifics of pharmaceutical engineering and regulatory trends in an unstable environment . In particular, Jean François Douliere, Pharmaceutical Senior Expert, Chair ISPE France Affiliate will talk about the changes in Annex 1 to the EU GMP Rules (review of the second version of the draft document dated December 2020); Dmitry Rozhdestvensky will give an overview of the current changes in the EAEU regulatory legal acts regarding the circulation of medicinal products for 2020; the Head of the Department for Inspection of Good Pharmaceutical Practices of the Scientific Centre of Drug and Medical Technology Expertise of the Ministry of Health after Academician Gabrielyan (Republic of Armenia) Mkrtich Shakaryan will give practical advice on the application of the EAEU regulatory legal acts in the field of GM(D)P, etc.
The presented material was prepared using data published on the official websites, as of early November 2020. Manufacturers of veterinary medicinal products are advised to follow the constantly updated information and are seriously preparing for the start of an inspection for compliance with the requirements of the Rules of Good Manufacturing Practice of the Eurasian Economic Union.
Konstantin Morozov, GMP Specialist of Ceva Sante Animale LLC
Статья: Сравнение и анализ требований GМP Российской Федерации и ЕАЭС.
Объединенный фармацевтический портал PharmaPharm / Статьи / Статьи экспертов / Регуляторные квесты и лабиринты, или кому на Руси жить хорошо: старая сказка на новый лад с фарма-акцентом. URL: https://pharmapharm.ru/stati/regulyatornye-kvesty-i-labirinty-ili-komu-na-rusi-git-chorosho-staraya-skazka-na-novyy-lad-s-farma-akcentom/ (дата обращения 02.11.2020)
Изменения в Правила надлежащей производственной практики. URL: http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/LS1/Pages/WP_LA_projects.aspx (дата обращения 02.11.2020)
ФБУ «ГИЛС и НП» / Документы / Инспектирование / Обзор основных нововведений в новой версии Приложения №16 к правилам GMP – «Требования к подтверждению Уполномоченным лицом соответствия серии продукции с целью ее выпуска».
Федеральный портал проектов нормативных правовых актов. О внесении изменений в приказ Россельхознадзора от 18.10.2016 № 755 «Об утверждении формы заявления о выдаче заключения о соответствии производителя (иностранного производителя) лекарственных средств для ветеринарного применения требованиям правил надлежащей производственной практики, формы инспекционного отчета по результатам инспектирования производителя (иностранного производителя) лекарственных средств для ветеринарного применения на соответствие требованиям правил надлежащей производственной практики и формы заключения о соответствии производителя (иностранного производителя) лекарственных средств для ветеринарного применения требованиям правил надлежащей производственной практики». URL: https://regulation.gov.ru/projects#npa=109167(дата обращения 02.11.2020)
Совместная программа содействия внедрению лучших образцов надлежащих практик в российской фармацевтической отрасли / Открытые семинары и вебинары. URL: https://www.goodpractices.ru/anonce/ (дата обращения 02.11.2020)
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.
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).
Philip Morris International Inc. announced it has entered into an agreement to acquire Fertin Pharma A/S (Fertin Pharma), a leading developer and manufacturer of innovative pharmaceutical and well-being products based on oral and intra-oral delivery systems, for an enterprise value of DKK 5.1 billion (approximately USD 820 million). “The acquisition of Fertin Pharma will be a significant step forward on our journey toward delivering a smoke-free future—enhancing our smoke-free portfolio, notably in modern oral, and accelerating our progress in beyond nicotine,” stated Jacek Olczak, Chief Executive Officer. “Both PMI and Fertin share a commitment to science and consumer-centric innovations for better living, and I am delighted we have reached this agreement. Fertin’s diverse portfolio of technologies, evolving business mix, and world-class expertise will enrich our innovation pipeline and capabilities, providing speed and scale in oral delivery to support our 2025 goals of generating more than 50% of our net revenues from smoke-free products and at least USD 1 billion from products beyond nicotine.” Fertin Pharma is a privately held company with more than 850 employees and operations in Denmark, Canada, and India. It is a leading contract development and manufacturing organization (CDMO), specializing in the research, development and production of […]
There are currently 59 Ph. Eur. texts – covering a variety of topics including vaccines for human use, blood products, antibiotics, radiopharmaceuticals and containers – that refer to the RPT and will be affected.
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 […]
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.
Johnson & Johnson has shaken off another lingering liability claim in the US, agreeing a $263 million settlement with New York to resolve lawsuits focused on its role in the US opioid crisis. The last-ditch agreement over the weekend means that a jury trial due to start today will now go ahead without J&J, although other defendants will still be in the spotlight. J&J also said in a statement that it committed to exiting its opioid painkiller business altogether last year. While the company didn’t provide finished opioid drugs, J&J supplied raw materials used to make them, and has been accused by various US states of using deceptive marketing to say the drugs were effective for treating pain and were unlikely to cause addiction. The settlement relates to its marketing and promotion of Duragesic (fentanyl), Nucynta (tapentadol) and Nucynta ER products, which are no lomger on sale in the US. The opioid epidemic has wreaked havoc on countless communities across New York state and the rest of the nation, leaving millions still addicted to dangerous and deadly opioids, – said NY attorney general Letitia James, – Johnson & Johnson helped fuel this fire, but today they’re committing to leaving the opioid business […]
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.
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 […]
A Russian military research unit that was involved in the development of Sputnik V is working on a new coronavirus vaccine in the form of chewing gum, the RBC news website reported Friday. The Defense Ministry’s 48th Central Research Institute collaborated with the state-run Gamaleya Research Institute in Moscow to develop and trial Sputnik V last year. Russia, facing accusations of rushing human trials, touted the adenoviral vector vaccine as the world’s first to be approved for widespread use. Citing an unnamed Defense Ministry source and confirmation from the 48th Central Research Institute’s director, RBC said “work is underway” toward developing a mucosal Covid-19 vaccine in the form of chewable tablets and pastilles. “After testing, the drug will be included in various treatment and prevention regimens for coronavirus,” the source was quoted as saying. Col. Sergei Borisevich, who heads the 48th Central Research Institute, confirmed work on the new vaccine but did not specify what stage it was at. Russia has registered a total of four coronavirus vaccines and has reached agreements with close to 70 countries on selling Sputnik V or sharing the technology to manufacture it. Moscow’s active efforts to market the two-shot vaccine around the world has been viewed […]
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.
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 […]
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.
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 factory, which will be located on a 42 hectare greenfield site is planned to be operational by 2023, will be run by Recipharm and will mirror the company’s new fill finish line at its facility in Monts, France on a larger scale.
The 67,000-square-foot facility, located on Thermo Fisher’s Carlsbad campus, is part of an investment strategy to ensure customers can reliably meet growing global demand for cell and gene therapies and vaccines.
The global active pharmaceutical ingredient market stood at around $190 billion in 2020, and it is expected to reach approximately $300 billion by 2030. This can be attributed to the widening of the application area of drugs, expiration of patented biologics, increase in the incidence of chronic and lifestyle-associated diseases, such as cancer, diabetes, and cardiovascular diseases, rise in the geriatric population, government initiatives to promote generic drugs, investments in biosimilars, increasing healthcare expenditure, and surging awareness about diseases. Due to the COVID-19 pandemic, lockdowns were imposed by the government in several countries across the world, which disrupted the supply chain and economic activity during the first half of 2020. However, established pharmaceutical and biotech companies, as well as research institutes, stepped forward to develop a treatment against the coronavirus, which had a positive impact on the API market. Due to High Investments by Major Players, Captive Category Held Larger Share The captive category held the larger share in the active pharmaceutical ingredient market during 2015–2020, and it is expected to retain its position in the upcoming years, based on the type of manufacturer. This can be attributed to the easy availability of raw materials and surging investments by the […]
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 […]
Governments around the world struggle with the logistical challenges of procuring, deploying and administering vaccines at scale. To deliver the vaccines, pharmaceutical companies, logistical partners and governments have come together to create a “cold chain” that ensures vaccines are kept at precise temperatures—adding a major layer of complexity to the delivery of vaccines. The Role of Good Distribution Practices Clearly there’s still much that can be done from a logistical standpoint to ensure the various vaccines are able to reach the people who need them. Complexity and challenges can be found throughout the vaccine cold chain, but one major factor working in our favor is the emergence of new technology and infrastructure that will help ensure the integrity of the vaccine cold chain. Good Distribution Practices (GDP) that describe calibration of all temperature measurement instruments and storage devices are moving from recommendations to requirement—and the quicker they’re adopted and integrated into vaccine logistics globally, the sooner the promise of vaccine prevention could help end the pandemic. GDP was created in U.S. by the FDA, but at present they’re only recommendations and not requirements. Unfortunately, during the pandemic little progress has been made in implementing them more fully, but if they had […]
German biotechnology company BioNTech SE, based in Mainz, and Siemens intend to expand their strategic cooperation. The companies plan to intensify their collaboration for the rapid expansion and creation of production capacity for the Covid-19 vaccine. BioNTech has expressed its aim of establishing new production sites for Covid-19 vaccine production worldwide based on the Marburg plant and its technology, starting with a production facility in Singapore. In Marburg, BioNTech has converted an existing plant into a vaccine production facility with support from Siemens in just five months. Within this cooperation, Siemens will provide the latest automation and digitalization technologies for BioNTech production sites, such as design, simulation, and engineering software as well as process control technology.
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.
Interleukin-6 blocking drugs – tocilizumab and sarilumab – act to suppress this overreaction. WHO has launched an expression of interest for prequalification of manufacturers of interleukin-6 receptor blockers.
Walmart announced the launch of the first-ever private brand analog insulin, which will revolutionize the access and affordability to diabetes care by offering customers a significant price savings without compromising quality. Available exclusively through Walmart’s private ReliOn brand, the new offering includes analog insulin vials ($72.88) and FlexPen® ($85.88). These products will save customers1 between 58% to 75% off the cash price of branded analog insulin products, which translates to a savings of up to $101 per branded vial or $251 per package of branded FlexPens®. The new private label ReliOn™ NovoLog® Insulin (insulin aspart) injection, manufactured by Novo Nordisk, is available in Walmart pharmacies this week, and Sam’s Club pharmacies in mid-July across the United States. ReliOn™ NovoLog® is a rapid-acting insulin analog used to control high blood sugar in adults and children with diabetes. Customers will need a prescription in order to purchase the products and should always consult with their doctor regarding their diabetes management. “We know many people with diabetes struggle to manage the financial burden of this condition, and we are focused on helping by providing affordable solutions. We also know this is a condition that disproportionately impacts underserved populations. With ReliOn NovoLog® insulin, we’re […]
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 […]
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.
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.
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 […]
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.
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 […]
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 […]
The Heads of the World Bank Group, International Monetary Fund, World Health Organization, and World Trade Organization today convened for the first meeting of the Task Force on COVID-19 Vaccines, Therapeutics and Diagnostics for Developing Countries. They issued the following joint statement: “As many countries are struggling with new variants and a third wave of COVID-19 infections, accelerating access to vaccines becomes even more critical to ending the pandemic everywhere and achieving broad-based growth. We are deeply concerned about the limited vaccines, therapeutics, diagnostics, and support for deliveries available to developing countries. Urgent action is needed now to arrest the rising human toll due to the pandemic, and to halt further divergence in the economic recovery between advanced economies and the rest. We have formed a Task Force, as a “war room” to help track, coordinate and advance delivery of COVID-19 health tools to developing countries and to mobilize relevant stakeholders and national leaders to remove critical roadblocks—in support of the priorities set out by World Bank Group, IMF, WHO, and WTO including in the joint statements of June 1 and June 3, and in the IMF staff’s $50 billion proposal. At today’s first meeting, we discussed the urgency of increasing supplies of vaccines, […]
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 […]
This review contains the latest information related to inspection of manufacturers of veterinary medicinal products manufactured outside the Russian Federation for compliance with the requirements of the Good Manufacturing Practice (GMP). These inspections are conducted 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. GMP rules Since January 2021, the GMP Rules of the Eurasian Economic Union (EAEU GMP Rules), approved by the Resolution of the EEC Council No. 77 of November 3, 2016, entered into force with respect to medicinal products for veterinary use . In January 2021, on the Official Internet Portal of Legal Information publication.pravo.gov.ru the Order of Rosselkhoznadzor No. 1231 of November 17, 2020 “On approval of the application form for issuing a conclusion on the compliance for a manufacturer (foreign manufacturer) of veterinary medicinal products with the GMP Rules requirements, the form of the inspection report based on the results of the inspection of the manufacturer (foreign manufacturer) of veterinary medicinal products for compliance with the GMP Rules requirements and the form of the conclusion on the compliance of the manufacturer (foreign manufacturer) of veterinary medicinal products with […]
In October 2020, the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) announced that from January 1, 2021, the Rules of Good Manufacturing Practice of the Eurasian Economic Union, approved by the Resolution of the Council of the Eurasian Economic Commission of November 3, 2016 No. 77, will come into force, in relation to medicinal products for veterinary use. Compliance with these Rules will be taken into account when issuing permits (licenses) to manufacturers of medicinal products for animals for these activities, as well as when inspecting them . In this short overview, we’ll look at some of the articles, presentations and documents that veterinary manufacturers may find useful. EAEU GMP rules The text of the Rules of Good Manufacturing Practice of the Eurasian Economic Union (the EAEU GMP Rules) is published on the website of the Eurasian Economic Commission (EEC) in the section “Resolutions of the Council of the Eurasian Economic Commission” . The EAEU GMP rules were approved in 2016. They entered into force in 2017, with the exception of the provisions of these Rules concerning the requirements for the production of veterinary medicinal products. The requirements of the EAEU GMP Rules for the manufacture of veterinary medicinal […]
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%.
The World Health Organization (WHO) and its COVAX partners are working with a South African consortium comprising Biovac, Afrigen Biologics and Vaccines, a network of universities and the Africa Centres for Disease Control and Prevention (CDC) to establish its first COVID mRNA vaccine technology transfer hub. The move follows WHO’s global call for Expression of Interest (EOI) on 16 April 2021 to establish COVID mRNA vaccine technology transfer hubs to scale up production and access to COVID vaccines. Over the coming weeks, the partners will negotiate details with the Government of South Africa and public and private partners inside the country and from around the world. South African President Cyril Ramaphosa said: “The COVID-19 pandemic has revealed the full extent of the vaccine gap between developed and developing economies, and how that gap can severely undermine global health security. This landmark initiative is a major advance in the international effort to build vaccine development and manufacturing capacity that will put Africa on a path to self determination. South Africa welcomes the opportunity to host a vaccine technology transfer hub and to build on the capacity and expertise that already exists on the continent to contribute to this effort.” This is great news, particularly for […]
Vietnamese Prime Minister Pham Minh Chin has requested accelerating the transfer of vaccine production technology and the testing and production of home-grown vaccine for COVID-19, so that Vietnam will be able to produce COVID-19 vaccines no later than June 2022. The Company for Vaccine and Biological Production No.1 (Vabiotech) – the biggest vaccine manufacturer and supplier for the EPI in Vietnam is in talks with Russia to produce Sputnik V vaccine in the country. He made the order during working sessions with several producers of vaccines, biological products and medical supplies in Hanoi on June 24. At the Vaccine and Biological Production Company No. 1 under the National Institute of Hygiene and Epidemiology, the PM also reiterated the need to carry out the vaccination campaign in the quickest, most effective and safest manner. (VietnamPlus, Vietnam News Agency) During a working session with Medicon company which specialises in producing test kits for medical needs, the PM asked the company to keep up its creative spirit in research and production of medical products, including medical supplies for COVID-19 prevention and control. Successful realization of the vaccine strategy is the top solution to prevent and push back the COVID-19 pandemic as Vietnam, one […]
For the first quarter of 2021 NPO Microgen, managed by the Nacimbio holding of the Rostec State Corporation, has increased the export of medicinal products to Uzbekistan by more than one and a half times compared to the same period last year. By volume, about 500 thousand packages of medicines have been exported to the republic. The medicines of the pharmacological group of bacteriophages, registered in the country in 2019, turned to be the key sales driver. Their ratio was about 40% of total sales. Sextafag, supplied to Uzbekistan since 2018, was in the highest demand. In the first quarter of this year alone, its sales to the republic exceeded the total annual sales volume of the drug in 2020 by 60%. Sextafag has a broad spectrum of antimicrobial action and is designed for the treatment and prevention of pyoinflammatory and enteric diseases caused by staphylococci, streptococci, Proteus mirabilis, Klebsiella, Pseudomonas, and E. coli. Moreover, wholesale supplies to the republic of two types of bacteriophages (Intesti and Staphylococcus bacteriophage) were arranged for the first time. For the Staphylococcus bacteriophage a new, more convenient dosage form of 20 ml was registered in Uzbekistan last year. The Republic of Uzbekistan is Microgen’s […]
Yposkesi, a leading Contract Development and Manufacturing Organization (CDMO) specializing in cell and gene therapies, announces the launch of project SKY, the construction of Yposkesi’s second commercial cell and gene therapy facility and new global resource for drug developers of biologics, also called ATMPs (Advanced Therapy Medicinal Products). ATMPs treat patients living with rare and life-threatening diseases. To accelerate innovation, in March 2021 Yposkesi welcomed SK Pharmteco, a global CDMO player, as a new majority equity shareholder in its company. Backed by SK Pharmteco, Yposkesi is investing €58M (approx. $71M) in the new 5,000m² site, making it one of the largest ATMP facilities in Europe. Project SKY will create approximately 80 new jobs by 2023. With this new state-of-the-art facility, designed for European and American GMP compliance, Yposkesi will double its production surface to 10,000m². This new resource equips it to address the shortage in manufacturing capacity for drug developers seeking to advance clinical trials and commercialize new therapeutic drugs. Yposkesi is proud and excited to embark full speed on this new phase in our development. SKY is the culmination of our industrial strategy, guaranteeing clients a range of quality services from early clinical drug development through all phases to […]
Servier, a global independent pharmaceutical Group, and PRISM BioLab, a Japan based biotechnology company with proprietary small molecule drug discovery platform, “PepMetics™Technology”, today announced that they have entered into a Collaboration and Exclusive License Option Agreement. Under the collaboration agreement, PepMetics™ technology provided by PRISM BioLab are utilized to identify from their library or synthetize, characterize, and optimize small molecule compounds capable of binding and stimulating the activity of the target specified by Servier. Wesley Blackaby, Ph.D, Head of Chemistry at Servier says: “We look forward to working with PRISM BioLab in this collaboration. The PRISM BioLab technology has the potential to help with the identification and optimization of novel compounds against hard to drug targets, in particular in cancer, which is one of the Group’s priority R&D areas.” Upon finding the lead compounds, Servier has the option to license the lead compounds for further optimization and clinical development. PRISM BioLab will receive collaboration fee and option fees payments under the Option Agreement, and further milestones and royalty payments under the License Agreement. Specific financial terms are not disclosed. Dai Takehara, President and CEO, PRISM BioLab, says: “We are delighted to partner with Servier who is committed to delivering therapy […]
An application for the registration of the anti-COVID vaccine EpiVacCorona-N has been submitted to the Russian Health Ministry for registration, as follows from a post uploaded to the state register of medicines. Earlier, the CEO of the State Research Center of Virology and Biotechnology Vector, Rinat Maksyutov, said there were no fundamental distinctions between EpiVacCorona-N and the previous version EpiVacCorona. EpiVacCorona, developed at the State Research Center of Virology and Biotechnology Vector, was a second vaccine to have been registered in Russia. The registration certificate was issued on October 14, 2020. About a month later the vaccine’s developers were given permission to conduct post-registration research in different groups of patients, including elderly people.
Russia has put into circulation about 32 million sets of coronavirus vaccines since the beginning of the year, and new sites are joining in the production effort to ensure vaccination, the Industry and Trade Ministry told TASS. “All the four national vaccines are produced rhythmically in line with the plans drawn up together with the manufacturers. The difference in their time availability is caused by different times of their registration, namely August 2020 (Sputnik V), October 2020 (EpiVacCorona), February 2021 (CoviVac) and May 2021 (Sputnik Light),” the Industry and Trade Ministry said. Since the beginning of the year, more than 30 million sets of Sputnik V, nearly 1.5 million [sets] of EpiVacCorona and 352,000 [sets] of CoviVac, which was registered later than the first two vaccines, have been put into circulation,” the ministry said noting that the difference in the vaccines’ availability was caused by different timeframes of their authorization. The press service explained that from the stage of authorization to large-scale production, each vaccine had to undergo a series of steps related to the scaling up of technology and quality control of the vaccines. “New production sites are joining in the production of each of the vaccines to ensure […]