scholarly journals Justification of Safety of Homeopathic Medicines in a Registration Dossier

2019 ◽  
Vol 7 (4) ◽  
pp. 200-215
Author(s):  
R. D. Subaev ◽  
G. N. Engalycheva ◽  
D. V. Goryachev
Keyword(s):  
Scientific Literature ◽  
The European Union ◽  
Objective Criterion ◽  
Additional Information ◽  
Registration Data ◽  
Eurasian Economic Union ◽  
Bibliographic Data ◽  
The Russian Federation ◽  
Simplified Procedure ◽  
Registration Dossier

Regulatory approaches to assessing the safety of homeopathic medicines in the Russian Federation and abroad are formed in accordance with regulatory acts, national and international rules and guidelines. Scientific literature is particularly important for justification of safety of homeopathic medicines. The purpose of this study was to determine the requirements and procedure for presenting justification of homeopathic medicines safety in the registration dossier in accordance with the documents of the Eurasian Economic Union and the European Union. According to the current Russian and foreign regulatory approaches the safety may be justified by scientific literature data on homeopathic use and by substantiation of the dosage in the case of medicines that have long experience of safe use and those that are authorized under a simplified procedure based on a dossier with a product instruction that does not establish indications for use. In both cases, there is no need to provide the results of preclinical or clinical studies of the drug. This approach reflects specific features of homeopathic medicines. An objective criterion of the safety of homeopathic medicines is the assessment of the dosage of active substances, taking into account the «first safe dilution» of homeopathic substances. A formal safety justification using registration data for similar drugs or additional information on the use of these pharmaceutical substances in homeopathy is also possible, but may be insufficient. The completeness and proper documentation of bibliographic data are the main criteria for an appropriate rationale for the safety of homeopathic products. 

scholarly journals Differences between the European and Eurasian Good Pharmacovigilance Practices

2021 ◽  
Vol 9 (2) ◽  
pp. 75-84
Author(s):  
A. V. Matveev ◽  
A. E. Krasheninnikov ◽  
E. A. Matveeva ◽  
B. K. Romanov
Keyword(s):  
Marketing Authorisation ◽  
European Medicines Agency ◽  
The European Union ◽  
Current Version ◽  
Eurasian Economic Union ◽  
Expert Analysis ◽  
The Russian Federation ◽  
Economic Union ◽  
Systems Effectiveness ◽  
The Eu

Good pharmacovigilance practices (GVP) of the Eurasian Economic Union (EAEU) were prepared based on the GVP of the European Medicines Agency that have been in force in the European Union (EU) since 2012. The EAEU GVP have been in force in the Russian Federation and the other EAEU member states since 2016. It is important to identify potential differences between the current regulations in order to harmonise requirements for the pharmacovigilance systems in the EU and EAEU. The aim of the study was to analyse and compare GVP requirements in the EU and EAEU. The analysis helped to identify differences in the structure and contents of GVP sections, the definitions of terms (EU GVP definitions are more detailed and supported by examples, subsections, and references to other documents). Moreover, supplements and annexes to the EU GVP contain figures, templates, examples, algorithms, and tables, which are missing in the EAEU GVP. Expert analysis of these differences as applied to assessment of the pharmacovigilance systems’ effectiveness, and practical activities of marketing authorisation holders, medicine developers, and regulatory authorities, demonstrated that the two GVPs are sufficiently harmonised and have very few differences. However, the number of differences between the documents increases, as changes are made to the EU GVP. A more comprehensive harmonisation of the EAEU GVP with the current version of the EU GVP will make it possible to develop and use uniform pharmacovigilance documents in the EU and EAEU, and will facilitate the introduction of EAEU medicines into the global pharmaceutical market.

scholarly journals Preparation of a Nonclinical Overview Based on Scientific Literature

2021 ◽  
Vol 11 (4) ◽  
pp. 263-272
Author(s):  
G. N. Engalycheva ◽  
R. D. Syubaev
Keyword(s):  
Literature Review ◽  
Medicinal Product ◽  
Scientific Literature ◽  
Preclinical Data ◽  
Eurasian Economic Union ◽  
Benefit Risk Assessment ◽  
Toxicological Data ◽  
Speed Up ◽  
Registration Dossier ◽  
Methodological Aspects

Current requirements for the registration dossier include submission of a preclinical (nonclinical) overview, including scientific literature data on preclinical studies and actual preclinical data on the medicinal product. For some groups of medicines, scientific literature data may be used instead of actual preclinical data, which may be redundant. One of the important functions of the scientific literature review is the analysis of updated preclinical information on the medicinal product, which reflects the product’s characteristics, supports conclusions on its efficacy or safety, and may affect the results of the benefit/risk assessment. The aim of the study was to determine the optimal format for presenting scientific literature data in a nonclinical overview that would reflect the methodological aspects of preclinical pharmacology and toxicology studies of medicines. The authors analysed the regulations of the Russian Federation and the Eurasian Economic Union containing requirements for the scientific literature review submitted instead of actual preclinical data as part of the registration dossier for a medicinal product. The authors also considered potential difficulties in preparing a nonclinical overview based on scientific literature. In order to systematise scientific literature data, it is recommended to provide pharmacodynamic, pharmacokinetic, and toxicological data using a format consistent with the common technical document. The proposed recommendations help to harmonise the process of preparation and design of a nonclinical overview which should contain data and facts enabling a reasoned assessment of the benefit/risk ratio. The standardised format of literature data presentation will help the developer prepare an adequate nonclinical overview and will speed up assessment of clinical trial or marketing authorisation applications.

The Eurasian Economic Union: Problems and Prospects

2018 ◽  
pp. 722-749 ◽  
Author(s):  
Seljan Verdiyeva
Keyword(s):  
Decision Making ◽  
European Union ◽  
Russian Federation ◽  
Kyrgyz Republic ◽  
The European Union ◽  
Eurasian Economic Union ◽  
Economic Council ◽  
The Russian Federation ◽  
Economic Union ◽  
Eurasian Region

Abstract On 29 May 2014, during the meeting of Supreme Eurasian Economic Council, the Presidents of Russia, Belarus and Kazakhstan signed the Treaty on the Eurasian Economic Union (EAEU). Presently, the EAEU consists of the Russian Federation, Belarus, Kazakhstan, Armenia and the Kyrgyz Republic. Nonetheless, the EAEU is lobbying for an ambitious plan of enlargement and is aiming to expand across the entire Eurasian region. The EAEU claims to be the second union after the European Union with the deepest integration aspirations, containing similar institutions and decision-making approaches. This article argues that there are a number of challenges for the effective functioning of EAEU and that its Member States are not yet fully committed to liberalization in practice, contrary to the aspirations they are advocating.

scholarly journals Administrative regulation measures for foreign trade in the European union (on the example of the Republic of Poland) and in the Eurasian economic union (on the example of the Russian Federation)

2019 ◽  
pp. 101-105 ◽  
Author(s):  
V. A. Kardanov ◽  
V. N. Kulik
Keyword(s):  
European Union ◽  
Foreign Trade ◽  
Russian Federation ◽  
Main Task ◽  
The European Union ◽  
Goods And Services ◽  
Eurasian Economic Union ◽  
The Russian Federation ◽  
Economic Union ◽  
The Republic

The European Union is the largest trading partner for the Eurasian Economic Union. The multi-integration of the Eurasian Economic Union with foreign countries practically guarantees a positive result. The issues, related with non-tariff measures regulating foreign trade, have been considered in the article. For the countries of the Eurasian Economic Union and the Russian Federation in particular, in the near future, the main task should be step-by-step standardization and elimination of almost all non-tariff barriers to trade, as these values significantly aggravate the counter-trade in goods and services and hinder further integration. And this concerns, above all, the development towards the European Union.

scholarly journals Expert Evaluation of Pharmacovigilance System Documents Included in the Registration Dossier

2020 ◽  
Vol 8 (4) ◽  
pp. 191-197
Author(s):  
I. I. Snegireva ◽  
E. O. Zhuravleva ◽  
N. Yu. Velts
Keyword(s):  
Marketing Authorisation ◽  
Pharmacovigilance System ◽  
System Management ◽  
Eurasian Economic Union ◽  
Regulatory Submissions ◽  
Marketing Authorisation Holder ◽  
System Data ◽  
The Russian Federation ◽  
Registration Dossier ◽  
Authorisation Holder

The Russian Federation and the member states of the Eurasian Economic Union (EAEU) are working on the creation of a common pharmaceutical market. EAEU marketing authorisation may be granted to those pharmaceutical companies whose activities comply with the Good Pharmacovigilance Practice (GVP). The aim of the study was to analyse pharmacovigilance system documents submitted as part of registration dossiers of medicines and to identify problems that may arise during preparation of the pharmacovigilance system master file (PSMF). The authors analysed the PSMF, which makes part of the registration dossier, for compliance with the EAEU GVP requirements for submission, content, and completeness of all sections of the document. They identified the most common types of errors in PSMF preparation and analysed conditions when a PSMF is required or, alternatively, when a brief summary of the pharmacovigilance system of the marketing authorisation holder will suffice. The paper summarises specific aspects of incorporating pharmacovigilance system documents in regulatory submissions, as well as aspects of presenting pharmacovigilance system data when bringing the registration dossier in line with the EAEU requirements. This information may be useful for marketing authorisation holders who are the main stakeholders in the medicine authorisation process and who are directly involved in the pharmacovigilance system management during the authorisation and post-authorisation stages of the drug life-cycle.

scholarly journals Development of the national list of carcinogens, mutagens and reprotoxicants and its implementation in the regulation of the circulation of chemicals over the territory of the Russian Federation and member states of the Eurasian economic union

2021 ◽  
Vol 100 (9) ◽  
pp. 897-902
Author(s):  
Khalidya Kh. Khamidulina ◽  
Dinara N. Rabikova
Keyword(s):  
European Union ◽  
Russian Federation ◽  
The United States ◽  
Hazardous Substances ◽  
The European Union ◽  
Hazard Class ◽  
Eurasian Economic Union ◽  
The Russian Federation ◽  
Economic Union ◽  
Mutagenic Effects

Introduction. Highly hazardous chemicals that can cause distant and specific effects in the human body and various representatives of natural biota are circulating on the market. To develop effective measures to minimize the risk of chemicals exposure and to inform the general public in the countries of the European Union, the United States and many other countries, national lists of substances that are potentially dangerous due to one or another type of effect on the body are being created. There are no lists of chemicals with reprotoxic and mutagenic effects in the Russian Federation and the Eurasian Economic Union. There is also a need to update the list of substances with carcinogenic properties. The aim of the study. Creation of lists of chemicals with reprotoxic, mutagenic and carcinogenic effects, based on a single international harmonized approach to the assessment, hazard classification and labelling of these highly hazardous substances. Materials and methods. To achieve this goal, an analysis of the information was carried out on about two thousand substances included in the regulatory legal acts of the Russian Federation and the European Union, as well as on a huge array of data from domestic and foreign sources of information, using the principles of evidence-based medicine. Results. Based on the obtained data, lists of chemicals with reprotoxic, mutagenic and carcinogenic were formed. The list of chemicals according to the danger of impact on reproductive function and development of offspring, which consists of substances classified into two classes, as well as compounds that affect through lactation. Seventy-five substances were assigned to class 1, 46 were included in the second class, and 16 substances were allocated to a separate class that influences the newborn through lactation. The list of mutagenic effects included 589 chemical substances, and due to the lack of epidemiological data, the analysis did not allow any of the substances to be attributed to hazard class 1A, 438 substances were classified to hazard class 1B, 151 substances were classified to hazard class 2. As a result of the analysis, a list of carcinogens was formed, among which 133 substances were assigned to the 1st class, and 244 were classified to the 2nd hazard class. Conclusion. These lists, to implement the Technical Regulations of the Eurasian Economic Union “On the Safety of Chemical Products” (TR EAEU 041/2017), were included in Annex No. 7 of the Procedure for Forming and Maintaining the Register of Chemicals and Mixtures of the Eurasian Economic Union, and also formed the basis for coding production and consumption waste according to these effects.

PRACTICAL ASPECTS OF PRACTICAL ASPECTS OF COOPERATION BETWEEN THE STATE BORDER GUARD OF LATVIA AND FEDERAL SECURITY SERVICE BORDER GUARD SERVICE OF RUSSIAN FEDERATION

2016 ◽  
Vol 1 (6) ◽  
pp. 77
Author(s):  
Jekaterina Kuprijanova ◽  
Juris Livdāns ◽  
Iluta Arbidāne
Keyword(s):  
International Law ◽  
Russian Federation ◽  
Scientific Literature ◽  
The State ◽  
Border Security ◽  
Border Control ◽  
The European Union ◽  
The Russian Federation ◽  
The Common ◽  
The Republic

One of the main State Border Guard priorities is to maintain and develop the state border guarding system, according to the European Union external borders requirements, by fulfilling the conditions of the Schengen acquis. Schengen acquis provides that international cooperation in the field of border security can have multilateral, bilateral and local dimensions. In this context, an agreements concluded with bordering countries on cooperation in the field of border management is an effective tool to strengthen border security (EU Schengen Catalogue, 2002). In research as methodology are used scientific literature in the field of international law, treaties and agreements, the law of the Republic of Latvia, the State border guard of the internal regulations and the State border guard of unpublished materials. The Republic of Latvia and the Russian Federation cooperate in the field of development and implementation of coherent measures for the border control. Cooperation with RF is executed based on treaties and agreements concluded, as well, maintaining contacts between competent representatives of both countries at various management levels. The extensive cooperation between neighbouring countries on maintenance of security at the border results in the elucidation of the incidents occurring at the state border and other relevant issues, at the same time providing stability and security at the common border.

scholarly journals Russian Federation and the Development of Integration Processes in the modern World: Problems and Prospects

2020 ◽  
pp. 47-54
Author(s):  
S. Yu. Kashkin
Keyword(s):  
Russian Federation ◽  
Modern World ◽  
The European Union ◽  
Basic Model ◽  
Political Sciences ◽  
Eurasian Economic Union ◽  
General Scientific ◽  
The Subject ◽  
Soviet Space ◽  
The Russian Federation

The aim of the article is to analyze the concept and essence of the modern integration relations development, which reflect 2 basic trends — rivalry and cooperation of states and integration interstate associations. The subject of the article is the characteristics and peculiarities of the modern integration law and its basic model — the law of the European Union, as well as the latest trend of integration relations in the post-Soviet space. The article uses general scientific, philosophical and special legal methods of knowledge, and is based on the material of integration law and related legal and political sciences. According to the results, the article assesses the possible prospects for the development of integration relations in the world, especially for the Russian Federation and Eurasian Economic Union.

Competitiveness of energy-consuming devices: new requirements in technical regulation for sustainable development

2020 ◽  
Vol 27 (3) ◽  
pp. 11-18
Author(s):  
E.A. Sysoeva ◽  
◽  
T.A. Rozhkova ◽  
Keyword(s):  
Energy Efficiency ◽  
Energy Security ◽  
Positive Impact ◽  
The European Union ◽  
Technical Regulation ◽  
Member States ◽  
Eurasian Economic Union ◽  
Modern Level ◽  
Energy Consuming ◽  
Economic Union

The Eurasian economic Union has adopted the technical regulation «On energy efficiency requirements for energy-consuming devices» (TR EEU 048/2019), which is applied to widely used energy-consuming devices that have a significant share in the energy consumption balance and produce a significant impact on the energy security of the EEU member States. In TR EEU 048/2019 updated quantitative requirements to energy consuming devices, with new, additional requirements for energy efficiency, corresponding to modern level of the development of energy-saving technologies, and harmonization gradually introduced requirements on energy efficiency of energy consuming devices installed in a TR EEU 048/2019, with the requirements of the directives and regulations of the European Union, suggests that energy efficiency in energy-consuming products manufactured in the member States of the Eurasian economic Union, will steadily increase and it should have a positive impact on the competitiveness of energy-consuming goods produced in the territory of the Eurasian economic Union. The introduction of the EAEU TR 048/2019 is an urgent solution for ensuring energy security of the economies and the energies of the member States of the Eurasian economic Union and will promote the promotion of competitive energy-consuming products produced on the territory of the countries of the Eurasian economic Union to the international market and will allow the population to save money on acquisitions of energy efficient energy consuming devices.

Glembotskaya G.T., Eremin S.Yu. Scientific and practical approach to optimizing costs on development and promotion of drugs

2019 ◽  
Vol 2019 (3) ◽  
pp. 47-53
Author(s):  
Галина Глембоцкая ◽  
Galina Glembockaya ◽  
Станислав Еремин ◽  
Stanislav Eremin
Keyword(s):  
Scientific Literature ◽  
Pharmacological Action ◽  
Pharmaceutical Market ◽  
Pharmaceutical Companies ◽  
Strategic Development ◽  
The World ◽  
The Russian Federation ◽  
The Cost ◽  
Further Development ◽  
Registration Phase

In order to identify promising strategic development possibilities for the pharmaceutical industry in the Russian Federation, a pilot study was conducted, which has analyzed the main trends in the development of innovative medicines. As a result of the content analysis of available sources of scientific literature, the characteristics of options used in the world practice for increasing the innovative activity of individual subjects and the pharmaceutical market as a whole are presented. Possible reserves for the further development of the innovative component of the pharmaceutical market within the framework of the concept of personalized medicine according to the P4 principle (predictive - personalized - preventive - participatory) are identified and structured. The results of use by individual pharmaceutical companies of scientifically and practically justified approaches to optimizing the costs of development and promoting drugs are presented. The advantages and real prospects of a generally accepted method to reduce the cost of development by «expanding the pharmacological effect» (label expansion) of already existing drugs with a known safety profile in the world practice are shown. A scientific generalization and structuring of the goals and results of the post-registration phase of clinical trials to expand the pharmacological action of a number of drugs already existed at the market have been carried out.

Sign in / Sign up

Export Citation Format

Share Document