Suchergebnisse

The legislation of the Eurasian Economic Union (EAEU) includes all the necessary requirements and tools to implement a unified approach to preparing Module 1 of the electronic Common Technical Document (eCTD) for the concerned member states (CMSs). However, the approaches to the matter and the recommendations provided to applicants differ across member states. This causes significant ambiguity and imposes an excessive burden on the applicants. Drafting of a guideline on preparation of eCTD Module 1 for the CMSs will allow for tackling this important grey area in the EAEU regulatory framework, as regulatory authorities are lacking consensus on country-specific submissions. Currently, pharmaceutical industry stakeholders consider the Russian experience of implementing the legislation in question the most successful, so it is proposed to convey this experience to the common market of the EAEU. ; Законодательство Евразийского экономического союза (ЕАЭС) содержит все необходимые требования и инструменты для реализации единого подхода к подготовке Модуля 1 электронного регистрационного досье в формате общего технического документа для государств признания, однако в разных государствах-членах подходы и рекомендации заявителю отличаются. Это создает значительную неопределенность и увеличивает нагрузку на заявителей при проведении регистрационных процедур. Разработка проекта руководства по подготовке Модуля 1 для государств признания позволит устранить значительное «серое пятно» в нормативной правовой базе ЕАЭС, поскольку в настоящее время регуляторные органы государств — членов ЕАЭС не имеют единой позиции по вопросу предоставления страноспецифичных документов. Наиболее успешным опытом правоприменения в этом вопросе представителями фармацевтической отрасли признан опыт Российской Федерации, и именно его предлагается транслировать на общий рынок ЕАЭС.

Biological products or biopharmaceuticals are medicinal products derived from living organism systems and manufactured by using modern biotechnology that differ widely from the conventional synthetic drugs. According to some estimates, Russia is poised to be among the top five global pharmaceutical Markets in terms of value in the next couple of years. Due to the impetus shown by the government regarding the evolution of the Russian regulatory framework for pharmaceutical products, this and other market trends suggest that Russia will soon become a powerhouse destination for pharmaceutical manufacturers and contract research organizations. Russian law allows the registration of biological drugs defined as medicinal products containing a biological active substance. A bio­logical active substance is a substance that is produced by or extracted from a biological source and requires physical, chemical and biologi­cal testing, characterization of its quality, along with its production process and control. It does not define a biosimilar, nor it provides a regulatory framework for the biosimilar approval; this implies that a full clinical developmental program, similar to the innovator biologi­cal product, must be completed even for a biosimilar. An applicant must submit a registration dossier to the Ministry of Health (MoH), the regulatory body for drugs evaluation, with its affiliation Federal State Budgetary Institution - Scientific Centre for Expert Evaluation of Medicinal Products (FSBI-SCEMP). The complete dossier in Russian must be submitted to the MoH, and should include administrative doc­uments, description of pharmaceutical properties and data about the manufacturing process, quality control, preclinical studies (pharmaco­logical and toxicological) and clinical studies regarding the biological drug. Russia follows the European Guidelines for biosimilars for data requirements for the registration of a biological drug. Today, Russia stands on the verge of becoming a major force in the global pharmaceutical ...

Introduction. The inevitable of post-registration variations due to the improvement of production processes and quality control related to the integration of the modern technological solutions, replacement of equipment, suppliers of raw, consumables and packaging materials, improvement of form release or composition, administrative changes, as well as obtaining new data on clinical efficacy and safety of immunobiological medicinal products (IMP) during post-marketing studies.Text. The purpose of this work is to analyze the post-registration changes in the life cycle of IMP «Сholera bivalent chemical Vaccine» produced by Russian State anti-plague Research Institute «Microbe», reflecting the harmonization of the documents of the registration dossier with the innovations of the Russian legislation, the optimization of production and quality control. First of all, the changes made to the registration documentation for IMP concerned the updating of the dossier in accordance with the adopted Federal laws and Resolutions of the government of the Russian Federation. The following changes related to the optimization of methods for controlling the limit content of impurities of substances used at different stages of antigen production. Also, the changes were associated with the improvement of consumer properties of the drug, namely the introduction of modern polymer packaging and several drug's form release, convenient for use in practical health care institutions. The latest change of Pharmacopoeia enterprise article (PEA) R N001465/01-111119 regulates the application of identification means in the form of a two-dimensional bar code (QR-code) on the packaging of medicines, which is due to compliance with the requirements of article 67 «Information on medicines. The system of monitoring the movement of medicines» Federal law N 61 «Оn medicines circulation».Conclusion. Maintaining the required level of quality of IMP when changing production technology or control requires a comprehensive analysis of the proposed changes in order to make them in the documents of the registration dossier. At the same time harmonization of documents of the registration dossier with novelties of the Russian legislation is a necessary condition for implementation of production activity within the legal field. ; Введение. Неизбежность пострегистрационных изменений обусловлена совершенствованиями процессов производства и контроля качества, связанными с внедрением современных технологических решений, заменой оборудования, поставщиков сырья, расходных и упаковочных материалов, совершенствованием формы выпуска или состава, административными изменениями, а также получением новых данных о клинической эффективности и безопасности иммунобиологических лекарственных препаратов (ИЛП) в ходе постмаркетинговых исследований.Текст. Цель настоящего обзора – анализ пострегистрационных изменений в процессе жизненного цикла ИЛП «Вакцина холерная бивалентная химическая» производства ФКУЗ РосНИПЧИ «Микроб» Роспотребнадзора, отражающих гармонизацию документов регистрационного досье с нововведениями Российского законодательства, оптимизацию производства и контроля качества. В первую очередь, изменения, вносимые в регистрационную документацию на ИЛП, касались актуализации досье в соответствии с принятыми федеральными законами и постановлениями Правительства РФ. Следующие изменения относились к оптимизации методов контроля предельного содержания примесей веществ, используемых на различных стадиях производства антигенов. Также изменения были связаны с улучшением потребительских свойств лекарственного препарата, а именно внедрением современной полимерной упаковки и нескольких вариантов фасовки, удобной для применения в учреждениях практического здравоохранения. Последнее изменение ФСП регламентирует нанесение на упаковку лекарственных препаратов средства идентификации в виде двухмерного штрихового кода (QR-кода), что обусловлено выполнением требований статьи 67 «Информация о лекарственных препаратах. Система мониторинга движения лекарственных препаратов (МДЛП) для медицинского применения» Федерального закона № 61-ФЗ «Об обращении лекарственных средств».Заключение. Сохранение необходимого уровня качества ИЛП при изменении технологии производства или контроля требует всестороннего анализа предлагаемых изменений с целью последующего внесения их в документы регистрационного досье. При этом гармонизация документов регистрационного досье с новеллами российского законодательства является необходимым условием для осуществления производственной деятельности в рамках правового поля.

The article is devoted to the legal regulation study of simplified registration of veterinary medicinal products in the light of harmonization of Ukrainian legislation with EU legislation. It is noted that due to complexity of preparing a complete registration dossier, legislation of many countries, including EU countries have a number of possibilities for simplified registration of veterinary medicines by submitting a shortened list of registration dossier materials. The analysis of the relevant EU legislation has been carried out, in particular the provisions of Directive 2001/82/EC of the European Parliament related to simplified registration of veterinary medicines. It is determined that the EU law provides for the possibility of incomplete dossier submission in cases of registration of generic or hybrid veterinary medicinal products, veterinary medicinal products with well-studied veterinary use, veterinary medicines with a fixed combination, and veterinary medicinal products, that are registered with informed consent. It is noted that as a result of EU-Ukraine Association Agreement signing a new stage in the development of Ukrainian legislation regarding the turnover of veterinary medicinal products has begun, which is characterized by the increased impact of EU law on the legal regulation of this industry. It is proved that today legal regulation of simplified registration in Ukraine needs to be updated. Although Ukrainian system of veterinary medicinal products registration in general is similar to European system, level of legal regulation in EU is much higher.Further harmonization of veterinary legislation in Ukraine requires adoption of essential legal acts for regulation of veterinary medicines' trade and improvement of existing institutional mechanisms. At the same time, a balance between high quality, efficiency and safety of products with guaranteed business opportunities for legal manufacturers of veterinary medicinal products must be established. ; Статтю присвячено дослідженню особливостей правового регулювання спрощеної реєстрації ветеринарних препаратів у світлі гармонізації законодавства України із законодавством ЄС. Відзначено, що у зв'язку зі складністю підготовки повного реєстраційного досьє в законодавстві багатьох країн, в тому числі країн Євросоюзу передбачено низку можливостей для спрощеної реєстрації ветеринарних препаратів шляхом подачі скороченого переліку матеріалів реєстраційного досьє. Здійснено аналіз відповідного законодавства ЄС, зокрема положень Директиви 2001/82 щодо спрощеної реєстрації ветеринарних препаратів. Визначено, що в праві ЄС передбачено можливість подачі неповного досьє у випадках реєстрації генеричних чи гібридних ветеринарних препаратів, ветеринарних препаратів з добре вивченим ветеринарним застосуванням, ветеринарних препаратів з фіксованою комбінацією, ветеринарних препаратів, що реєструються за інформованою згодою. Доведено, що на сьогодні правове регулювання такої реєстрації в Україні потребує вдосконалення.

Product registration in rest of world is a challenging task like regulated countries (US, EU & Japan) as they are not harmonized. It creates a difference in regulatory environment in Semi Regulated countries. Enormous diversity of regulatory requirements are found in this area. This region consists of mainly the countries from Asia pacific, Latin America, Eastern Europe, Africa and Gulf countries. Countries from Asia pacific and Gulf have somewhat harmonized their regulatory environment through The Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) organizations, ROW countries yet to be harmonized regulations in their respective regions. The urgent requirement to rationalize & harmonize regulation was required by instance of rising cost of health care, research & development and to meet the public requirement for safe and efficacious treatments to patient in need. ICH committee has given priority to harmonize the format of reporting data for quality, safety and Efficacy in the application dossier. The commercial significance of ROW markets is increasing globally. It is crucial that pharmaceutical companies keep up-to-date with the latest regulatory developments to ensure their place on the ROW market. This paper favors the regulatory processes for gaining marketing authorization in ROW countries in terms of technical data requirement for the dossier. Keywords: ROW, ASEAN, GCC, BMR, CIS, DMF, TSE/BSE, ICH, FP

This topic aims at reviewing the drug and drug product for filing and obtaining USFDA EMEA and TGA approval and its effective role to improve the standards which are laid by them. The respective Regulatory Agency approves the new/generic drug products that govern respective market before introduction of particular product into the market. The Regulatory Agency approves the entire new drug product to be safe and effective before marketing. USFDA is the Regulatory Agency which is responsible for the regulation of food and drug product in USA. EMEA is the Regulatory Agency which is responsible for the regulation of food and drug product in Europe. TGA is the Regulatory Agency which is responsible for the regulation of therapeutic goods in Australia. A dossier contains detail information about the drug substance and drug product and result of studies that are carried out in development process. For getting market authorization has to be submitted to the respective regulation bodies.CTD provides standardized structure. CTD makes filing easier globally. But there are differences in dossier submission requirements in these countries i.e. Module I is country specific and other regional guideline are also considered while compiling dossier application and Processing.

This report is provided in the scope of the project "Advancing REACH", funded by the research plan of the German Ministry of the Environment. The project aims to develop options to improve (the implementation of) the REACH regulation by analysing various REACH processes and related issues, including substitution, sustainable chemistry, precautionary principle, articles, cost-benefit analyses, socio-economic analyses and financing ECHA. The study analyses, under the perspective of the aims of the REACH Regulation, how the quality of registration dossiers could be improved. Starting point are empirical data, including those provided by ECHA, indicating that a relevant part of the registration dossiers does not meet the requirements set out in REACH. The study examines the requirements of the relevant legal mechanisms completeness check and dossier evaluation, as well as their practical implementation and, based on available data, the measurable effects of these. The report then develops "policy options" that can contribute to an improvement. An in-depth impact assessment of the presented options is not part of the study. Nevertheless, the results suggest that the legal context requires clarification. This applies to each of the analysed problem areas.

Background: Non-clinical and clinical overviews are an obligatory part of the Common Technical Document, that is the new format of the registration dossier in the Russian Federation and Eurasian Economic Union. Development of the overview demands on specific skills of the literature search and critical appraisal and also of systematization of scientific data. Goal of the paper consists of the description of the latest legislative rules about the development of the reviews for generic drug application by Russian national and EAEU rules and also practical experience of SMA LitReview. Conclusions: The review is one of the key elements of the generic drug dossier now in the Russian Federation and EAEU. In some cases, the review can replace the results of own trials of the Sponsor. Review process demands skills of the use of the international bibliographic databases, critical appraisal, good academic writing skills and also knowledge of modern Russian and EAEU law. ; Введение. Обзор доклинических и клинических исследований - обязательный элемент общего технического документа, нового формата регистрационного досье лекарственного средства для Российской Федерации, а также региона Евразийского экономического союза. Разработка обзора научных данных требует специальных компетенций от составителя по поиску, оценке и систематизации информации. Цель статьи в описании последних законодательных требований, предъявляемых к обзору научных работ для воспроизведенного лекарственного средства от национального регулятора и Евразийской экономической комиссии, на основании опубликованных нормативно-правовых актов и регуляторного опыта НМА Литобзор. Заключение. Обзор научных работ в современном типе регистрационного досье один из ключевых элементов документации по воспроизведенному лекарственному препарату, в определенных случаях обзор заменяет собственные результаты исследований Заявителя. Подготовка обзоров требует большого опыта использования международных библиографических баз данных, знаний в области критической оценки научных исследований и хорошего уровня академического письма, а также осведомленности в области актуального национального законодательства и документов ЕАЭС.

The management of post-approval changes to registration dossiers for medicinal products is one of the most important factors for ensuring sustainable quality, safety and efficacy of medicines. Competent authorities that use the module format of the registration dossier, i.e. the regulatory authorities of the European Union, USA and other members of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and the Eurasian Economic Union (EEU), issue guidelines on changes to registration dossiers for pharmaceuticals and biologicals (immunological products). Vaccines (finished dosage forms) and vaccine antigens (active ingredients) are a specific group of immunobiological products which have great prophylactic importance for healthcare, and which are associated with challenging development and specific methods of manufacturing and quality control. The procedure of introducing post-approval variations to dossiers for immunobiological medicinal products is poorly reflected in the current Russian and EEU regulations. The World Health Organization (WHO) established a procedure described in the «Guidelines on procedures and data requirements for changes to approved vaccines». The purpose of the present study was to compare current Russian and international legislation in terms of regulatory requirements for post-approval сhanges to dossiers for immunobiological products. The Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation is drafting Guideline on introducing post-approval changes into dossiers for immunobiological medicines. The draft includes a detailed review of various categories of changes based on their importance, and a list of conditions and required documents for specific groups of medicines. This article summarises scientific and methodological approaches to evaluation of changes introduced in registration dossiers for vaccines in order to further improve the regulatory framework of the Russian Federation and the EEU. ; Регулирование процесса внесения изменений в документы регистрационного досье является одним из важных факторов обеспечения стабильности качества, безопасности и эффективности лекарственных препаратов. Уполномоченные органы государств, поддерживающих модульный формат регистрационного досье: Европейского Союза, США, других стран-участниц Международного совета по гармонизации технических требований к лекарственным средствам для медицинского применения и Евразийского экономического союза (ЕАЭС), издают руководящие документы о внесении изменений в документы регистрационных досье на химико-фармацевтические и биологические (иммунологические) лекарственные средства. Вакцины (готовые формы) и вакцинные антигены (действующие вещества) представляют собой особую группу иммунобиологических лекарственных средств, характеризующихся высокой профилактической значимостью для здравоохранения, сложностью разработки, особыми методами производства и контроля. Порядок внесения изменений в документы регистрационного досье на иммунобиологическое лекарственное средство недостаточно отражен в действующих нормативно-правовых документах Российской Федерации и ЕАЭС. Всемирная организация здравоохранения рекомендует процедуру, описанную в документе «Руководство по процедурам и требованиям к данным, связанным с внесением изменений в зарегистрированные вакцины». Цель работы – проведение сравнительного анализа действующих отечественных и международных нормативно-методических документов в части регуляторных требований к процедуре внесения изменений в регистрационные досье зарегистрированных иммунобиологических лекарственных препаратов. В ФГБУ «НЦЭСМП» Минздрава России разрабатывается Проект методических рекомендаций по внесению изменений в регистрационные досье на зарегистрированные иммунобиологические препараты, который включает в себя детальное рассмотрение категорий значимости вносимых изменений, содержит условия и перечень необходимых документов для данной группы препаратов. В статье обобщены научно-методические подходы к экспертизе изменений, вносимых в регистрационное досье вакцины с целью дальнейшего совершенствования нормативно-правовой базы Российской Федерации и ЕАЭС.

The international community has been called upon to ramp up efforts to end statelessness and provided with a guiding framework of 10 Actions. This dossier presents the practical consequences of expulsion, both direct and indirect outcomes of collective violence, directed towards the Rohingyas. Touching upon the nexus between children's rights, human trafficking, and practical challenges associated on-the-ground, the dossier also discusses the imperative need for the Association of Southeast Asian Nations (ASEAN) states—collectively as a region—to take steps in fulfilling Action 7 of the Global Action Plan through the birth registration of Rohingya children as part of their existing efforts in order to enhance the protection of refugee children.

The Regulatory Affairs department is very often the first point of contact between the government authorities and the company. The attitudes and actions of Regulatory Affairs Professionals will condition the perceptions of the government officials to the company. Dossier is a collection or file of documents on the same subject, especially a file containing detailed information about a person or a topic. Any preparation for human use that is intended to modify or explore physiological systems or pathological states for the benefit of the recipient is called as "pharmaceutical product for human use". This guideline merely demonstrates an appropriate write-up format for acquired data. Throughout the ACTD, the display of information should be unambiguous and transparent, in order to facilitate the review of the basic data and to help a reviewer become quickly oriented to the application contents. This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier (CTD) applications that will be submitted to ASEAN regulatory authorities for the registration of pharmaceuticals for human use. This guideline describes a CTD format that will significantly reduce the time and resources needed to compile applications for registration and in the future, will ease the preparation of electronic documental submissions. ICH‐ECTD is an internationally driven standard designed to reduce cost in the administration, assessment and archiving of applications for marketing authorization of medicinal products for human use, to reduce the use of paper and streamline the assessment process making the system more efficient.

This report is provided in the scope of the project "Advancing REACH", funded by the research plan of the German Ministry for the Environment. The project aims to develop options to improve the implementation of REACH by analysing various REACH processes and related issues, including substitution, sustainable chemistry, precautionary principle, articles, cost-benefit analyses, socio-economic analyses and financing ECHA. The interfaces between the processes registration, dossier evaluation, substance evaluation, authorisation and restriction are described and analysed with regard to the intended interactions, existing instruments to support the interplay, observed deficits and improvement ideas. Based on this, findings on the main deficits and options to improve the interplay are summarised. Overall, the interplay between processes is assessed as working sufficiently well, with some improvement potential in the area of dossier and substance evaluation. An overarching deficit negatively affecting all process is the lack of hazard and use information at sufficient quality and level of detail in the registration dossiers.

Common Technical Document (CTD) provides a standardized structure for regulatory submissions that is acceptable in all ICH countries. Although the CTD makes multinational filings easier, there are significant differences in the dossier submission requirements in these countries. This study put forth the differences in registration requirements for generics in United States, Europe and India. Generic drugs in US they are approved under the Abbreviated New Drug Application. Bioavailability and Bioequivalence study data is critical in the generic drug approval process. For marketing authorization of the generic medicinal product in Europe, the applicant should submit abridged application to the relevant authority. The ability to accommodate country specific requirements and understand regulatory differences will have a substantial impact on the success of its multi country submissions strategy. Generic manufacturers must file an Abbreviated New Drug Submission (ANDS), and the CDSCO is controlled and governed by Directorate General of Health Services which comes under ministry of health and family welfare, Government of India. Medicinal products are highly regulated in the European Union (EU) and are subject to a separate, complicated system of approval procedures. Keywords: CTD, Generic drug, CDSCO, Bioequivalence, ANDS.

Common Technical Document (CTD) provides a standardized structure for regulatory submissions that is acceptable in all ICH countries. Although the CTD makes multinational filings easier, there are significant differences in the dossier submission requirements in these countries. This study put forth the differences in registration requirements for generics in United States, Europe and India. Generic drugs in US they are approved under the Abbreviated New Drug Application. Bioavailability and Bioequivalence study data is critical in the generic drug approval process. For marketing authorization of the generic medicinal product in Europe, the applicant should submit abridged application to the relevant authority. The ability to accommodate country specific requirements and understand regulatory differences will have a substantial impact on the success of its multi country submissions strategy. Generic manufacturers must file an Abbreviated New Drug Submission (ANDS), and the CDSCO is controlled and governed by Directorate General of Health Services which comes under ministry of health and family welfare, Government of India. Medicinal products are highly regulated in the European Union (EU) and are subject to a separate, complicated system of approval procedures. Keywords: CTD, Generic drug, CDSCO, Bioequivalence, ANDS

In order for a chemical plant protection product to be authorised for sale a registration dossier has to be assembled to demonstrate safety and efficacy to the satisfaction of government regulators. These studies and tests are protected for a period of 10 years in Europe, North America and some other jurisdictions from the date of first product authorisation so that only the data owner can gain commercial benefit from the data. Subsequent regulatory reviews which require new studies should not result in further periods of regulatory data protection exclusive use for the new data but compensation should be payable to the data generator. © 2016 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.