New role of extemporaneous manufacturing in regulating drug products access onto the market

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Abstract

The aim of the work was to study the legal aspects of the legislative regulation for manufacturing medicines in a pharmacy organization.Materials and methods. Databases of ConsultantPlus, Cyberleninka, Food and Drug Administration (FDA), European Medicines Agency (EMA), National Center for Biotechnology Information (NCBI), PubMed, e-library, WIPO Lex were used as search sources. The search was based on the following keywords and phrases: intellectual property, pharmacies+invention, patent, drugs, extemporal+production, orphan+diseases, as well as their Russian counterparts. 133 sources of information, including scientific articles and regulations, were found out; 50 have been included in this review. The analysis of information sources published from 2013 to 2023, was determined by the peculiarities of legislation changes in this area.Results. The article provided an overview of modern, including regulatory practice, pharmaceutical manufacturing in the Russian Federation, and also analyzed the benefits of this activity for the medical community, patients and the state. At the same time, the individualization of drug treatment has made it possible to work out systemic solutions for developing drug therapy methods for special groups of patients for whom the economic feasibility of a pharmaceutical registration and launching such drugs onto the market has been brought into challenge. In addition, pharmacy manufacturing is an accessible tool in the study of the drugs prescribed by a doctor not in accordance with the instructions for medical use (off-label) or in the dosage forms/dosages that are not on the market. Extemporaneous manufacturing can be also a part of the process of “repositioning” drugs on the market, subject to compliance with the requirements for pharmacy manufacturing and control of the prescribed drugs safety. The possibility of pharmaceutic drug manufacturing also makes it possible to partially resolve issues related to intellectual property. As a result of the carried out analysis, the following hypothesis was confirmed: the legislative changes have a similar legal assessment both in Russia and abroad and correspond to the legal practice in resolving intellectual property issues in relation to pharmacy organizations.Conclusion. The renewal of a pharmacy production will improve the availability of the drug care to the population, taking into account individual dosages and dosage forms in various therapeutic areas, and can also become a tool for repositioning drugs or clinical testing of new molecules for rare incurable diseases.
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临时生产在规范药品进入市场中的新作用
这项工作的目的是研究在药房组织中生产药品的立法条例的法律方面。材料和方法。使用了consulantplus、Cyberleninka、美国食品和药物管理局(FDA)、欧洲药品管理局(EMA)、国家生物技术信息中心(NCBI)、PubMed、e-library、WIPO Lex等数据库作为检索来源。搜索基于以下关键词和短语:知识产权、药房+发明、专利、药物、临时+生产、孤儿+疾病,以及它们的俄罗斯对应词。发现科学文献、法规等信息来源133个;其中50人被纳入本综述。对2013年至2023年发布的信息来源进行分析,是由该领域立法变化的特殊性决定的。本文概述了俄罗斯联邦的现代医药生产,包括监管实践,并分析了这一活动对医学界、患者和国家的好处。与此同时,药物治疗的个体化使得为特殊患者群体制定药物治疗方法的系统解决方案成为可能,对这些患者来说,药物注册和将此类药物投放市场的经济可行性受到了挑战。此外,药品生产是研究医生不按照医疗使用说明(标签外)或未在市场上销售的剂型/剂量开出的药物的一种可获得的工具。临时生产也可以是药品在市场上“重新定位”过程的一部分,前提是符合药房生产和处方药安全控制的要求。药品生产的可能性也使得部分解决与知识产权有关的问题成为可能。分析结果证实了以下假设:俄罗斯和国外的立法变化具有相似的法律评估,并且与解决与药房组织有关的知识产权问题的法律实践相对应。考虑到各个治疗领域的个别剂量和剂型,药房生产的更新将改善向人口提供药物护理的情况,还可以成为重新定位药物或对罕见的不治之症的新分子进行临床试验的工具。
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