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    袪袝袚校袥携孝袨袪袧袗携 袧袗校袣袗: 小袨袙袪袝袦袝袧袧蝎袝 孝袝袧袛袝袧笑袠袠 袙 袧袗校袣袝 袠 袨袘袪袗袟袨袙袗袧袠袠 袙 袨袘袥袗小孝袠 袥袝袣袗袪小孝袙袝袧袧蝎啸 小袪袝袛小孝袙

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    This article reviews modern trends in development of new instruments, standards and approaches to drugs safety, efficacy and quality assessment in USA and EU that can be called by unique term 鈥 芦regulatory science禄 which is a new concept for Russian Federation. New education programs (curricula) developed by USA and EU universities within last 3 years are reviewed. These programs were designed in order to build workforce capable to utilize science approach for drug regulation. The principal mechanisms for financing research in regulatory science used by Food and Drug Administration are analyzed. There are no such science and relevant researches in Russian Federation despite the high demand as well as needs for the system for higher education and life-long learning education of specialists for regulatory affairs (or compliance).聽袙 褋褌邪褌褜械 褉邪褋褋屑芯褌褉械薪褘 褋芯胁褉械屑械薪薪褘械 褌械薪写械薪褑懈懈 胁 褉邪蟹胁懈褌懈懈 薪芯胁褘褏 懈薪褋褌褉褍屑械薪褌芯胁, 褋褌邪薪写邪褉褌芯胁 懈 锌芯写褏芯写芯胁 泻 芯褑械薪泻械 斜械蟹芯锌邪褋薪芯褋褌懈, 褝褎褎械泻褌懈胁薪芯褋褌懈, 泻邪褔械褋褌胁邪 懈 写械泄褋褌胁懈褟 谢械泻邪褉褋褌胁械薪薪褘褏 褋褉械写褋褌胁 胁 小楔袗 懈 褋褌褉邪薪邪褏 袝胁褉芯锌械泄褋泻芯谐芯 褋芯褞蟹邪, 芯斜褗械写懈薪褟械屑褘械 胁 薪邪褋褌芯褟褖械械 胁褉械屑褟 薪芯胁褘屑 写谢褟 袪芯褋褋懈泄褋泻芯泄 肖械写械褉邪褑懈懈 褌械褉屑懈薪芯屑 芦褉械谐褍谢褟褌芯褉薪邪褟 薪邪褍泻邪禄. 袩褉懈胁械写械薪 芯斜蟹芯褉 褋芯胁褉械屑械薪薪褘褏 蟹邪褉褍斜械卸薪褘褏 芯斜褉邪蟹芯胁邪褌械谢褜薪褘褏 锌褉芯谐褉邪屑屑, 褉邪蟹褉邪斜芯褌邪薪薪褘褏 褍薪懈胁械褉褋懈褌械褌邪屑懈 小楔袗 懈 褋褌褉邪薪 袝胁褉芯锌械泄褋泻芯谐芯 褋芯褞蟹邪 蟹邪 锌芯褋谢械写薪懈械 3聽谐芯写邪 褋 褑械谢褜褞 锌芯写谐芯褌芯胁泻懈 泻邪写褉芯胁, 褌褉械斜褍械屑褘褏 写谢褟 锌褉懈屑械薪械薪懈褟 薪邪褍褔薪芯谐芯 锌芯写褏芯写邪 锌褉懈 褉械谐褍谢懈褉芯胁邪薪懈懈 谢械泻邪褉褋褌胁械薪薪褘褏 褋褉械写褋褌胁. 袩褉械写褋褌邪胁谢械薪褘 芯褋薪芯胁薪褘械 屑械褏邪薪懈蟹屑褘 褎懈薪邪薪褋懈褉芯胁邪薪懈褟 懈褋褋谢械写芯胁邪薪懈泄 胁 芯斜谢邪褋褌懈 褉械谐褍谢褟褌芯褉薪芯泄 薪邪褍泻懈, 懈褋锌芯谢褜蟹褍械屑褘械 胁 小楔袗. 袙 袪芯褋褋懈泄褋泻芯泄 肖械写械褉邪褑懈懈 锌芯泻邪 褌邪泻芯械 薪邪锌褉邪胁谢械薪懈械 薪邪褍泻懈 懈 褋芯芯褌胁械褌褋褌胁褍褞褖懈械 懈褋褋谢械写芯胁邪薪懈褟 薪械 锌褉芯胁芯写褟褌褋褟, 褏芯褌褟 锌芯褌褉械斜薪芯褋褌褜 胁 薪懈褏 写芯褋褌邪褌芯褔薪芯 胁褘褋芯泻邪, 褌邪泻 卸械 泻邪泻 懈 薪械芯斜褏芯写懈屑芯褋褌褜 胁 褋芯蟹写邪薪懈懈 褋懈褋褌械屑褘 锌芯写谐芯褌芯胁泻懈 懈 锌芯胁褘褕械薪懈褟 泻胁邪谢懈褎懈泻邪褑懈懈 褋锌械褑懈邪谢懈褋褌芯胁 锌芯 褉械谐褍谢懈褉芯胁邪薪懈褞 谢械泻邪褉褋褌胁械薪薪褘褏 褋褉械写褋褌胁.

    校袩袪袗袙袥袝袧袠袝 袠袟袦袝袧袝袧袠携袦袠 校小袥袨袙袠袡 袪袝袚袠小孝袪袗笑袠袠 袥袝袣袗袪小孝袙袝袧袧蝎啸 袩袪袝袩袗袪袗孝袨袙: 袧袨袙袨袝 袪校袣袨袙袨袛小孝袙袨 ICH Q12

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    Introduction of amendments to the registration dossier is the responsibility of the marketing application holder (MAH). Increased knowledge on pharmaceuticals, its manufacturing and control processes can reduce the number of documents submitted to the regulatory authorities. The existing requirements establishing the procedure for the introduction of amendments differ in terms of change classification, period of notification of regulatory authorities, ways of conformity validation of pharmaceutical properties, etc. ICH proposed draft guideline Q12 芦Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management禄 which covers the problem of harmonization of regulatory approaches to the changes provided in the 芦Quality禄 section of CTD during the commercial phase of drug life cycle. The new guideline can be considered as the continuation and elaboration of previous ICH documents. The article provides explanations on the main provisions and regulatory mechanisms introduced by the draft guideline ICH Q12: categorization of post-approval changes, established conditions, post-approval change management protocol, and drug product lifecycle management.袙薪械褋械薪懈械 懈蟹屑械薪械薪懈泄 胁 褉械谐懈褋褌褉邪褑懈芯薪薪芯械 写芯褋褜械 褟胁谢褟械褌褋褟 芯斜褟蟹邪薪薪芯褋褌褜褞 写械褉卸邪褌械谢褟 褉械谐懈褋褌褉邪褑懈芯薪薪芯谐芯 褍写芯褋褌芯胁械褉械薪懈褟 薪邪 谢械泻邪褉褋褌胁械薪薪褘泄 锌褉械锌邪褉邪褌. 校胁械谢懈褔械薪懈械 蟹薪邪薪懈泄 芯 谢械泻邪褉褋褌胁械薪薪芯屑 锌褉械锌邪褉邪褌械 懈 锌褉芯褑械褋褋邪褏 械谐芯 锌褉芯懈蟹胁芯写褋褌胁邪 懈 泻芯薪褌褉芯谢褟 屑芯卸械褌 褋锌芯褋芯斜褋褌胁芯胁邪褌褜 褋芯泻褉邪褖械薪懈褞 褔懈褋谢邪 写芯泻褍屑械薪褌芯胁 写谢褟 锌芯写邪褔懈 胁 褍锌芯谢薪芯屑芯褔械薪薪褘泄 褉械谐褍谢褟褌芯褉薪褘泄 芯褉谐邪薪. 小芯胁褉械屑械薪薪褘械 褌褉械斜芯胁邪薪懈褟, 褍褋褌邪薪邪胁谢懈胁邪褞褖懈械 锌芯褉褟写芯泻 胁薪械褋械薪懈褟 懈蟹屑械薪械薪懈泄, 褉邪蟹谢懈褔邪褞褌褋褟 胁 褔邪褋褌懈 懈褏 泻谢邪褋褋懈褎懈泻邪褑懈懈, 褋褉芯泻芯胁 褍胁械写芯屑谢械薪懈褟 褉械谐褍谢褟褌芯褉薪褘褏 芯褉谐邪薪芯胁, 褋锌芯褋芯斜芯胁 锌芯写褌胁械褉卸写械薪懈褟 褋芯芯褌胁械褌褋褌胁懈褟 褋胁芯泄褋褌胁 谢械泻邪褉褋褌胁械薪薪褘褏 锌褉械锌邪褉邪褌芯胁, 薪邪褉邪斜芯褌邪薪薪褘褏 写芯 懈 锌芯褋谢械 懈蟹屑械薪械薪懈泄, 懈 褌.锌. 袩褉械写谢芯卸械薪薪褘泄 ICH 锌褉芯械泻褌 褉褍泻芯胁芯写褋褌胁邪 Q12 芦孝械褏薪懈褔械褋泻懈械 懈 褉械谐褍谢褟褌芯褉薪褘械 邪褋锌械泻褌褘 褍锌褉邪胁谢械薪懈褟 卸懈蟹薪械薪薪褘屑 褑懈泻谢芯屑 谢械泻邪褉褋褌胁械薪薪芯谐芯 锌褉械锌邪褉邪褌邪禄 锌芯褋胁褟褖械薪 锌褉芯斜谢械屑械 谐邪褉屑芯薪懈蟹邪褑懈懈 褉械谐褍谢褟褌芯褉薪褘褏 锌芯写褏芯写芯胁 泻 懈蟹屑械薪械薪懈褟屑, 胁薪芯褋懈屑褘屑 胁 褉邪蟹写械谢 芦袣邪褔械褋褌胁芯禄 褉械谐懈褋褌褉邪褑懈芯薪薪芯谐芯 写芯褋褜械 胁 锌芯褋谢械褉械谐懈褋褌褉邪褑懈芯薪薪褘泄 锌械褉懈芯写 卸懈蟹薪械薪薪芯谐芯 褑懈泻谢邪 谢械泻邪褉褋褌胁械薪薪芯谐芯 锌褉械锌邪褉邪褌邪. 袧芯胁芯械 褉褍泻芯胁芯写褋褌胁芯 屑芯卸薪芯 褉邪褋褋屑邪褌褉懈胁邪褌褜 泻邪泻 锌褉芯写芯谢卸械薪懈械 懈 褉邪蟹胁懈褌懈械 写褉褍谐懈褏 写芯泻褍屑械薪褌芯胁 ICH. 袙 褋褌邪褌褜械 邪胁褌芯褉褘 写邪褞褌 褉邪蟹褗褟褋薪械薪懈褟 锌芯 芯褋薪芯胁薪褘屑 锌芯谢芯卸械薪懈褟屑 懈 褉械谐褍谢褟褌芯褉薪褘屑 屑械褏邪薪懈蟹屑邪屑, 胁胁芯写懈屑褘屑 锌褉芯械泻褌芯屑 褉褍泻芯胁芯写褋褌胁邪 ICH Q12: 泻谢邪褋褋懈褎懈泻邪褑懈褟 锌芯褋谢械褉械谐懈褋褌褉邪褑懈芯薪薪褘褏 懈蟹屑械薪械薪懈泄, 褍褋褌邪薪芯胁谢械薪薪褘械 褍褋谢芯胁懈褟, 锌褉芯褌芯泻芯谢 褍锌褉邪胁谢械薪懈褟 锌芯褋谢械褉械谐懈褋褌褉邪褑懈芯薪薪褘屑懈 懈蟹屑械薪械薪懈褟屑懈 懈 褍锌褉邪胁谢械薪懈械 卸懈蟹薪械薪薪褘屑 褑懈泻谢芯屑 谢械泻邪褉褋褌胁械薪薪芯谐芯 锌褉械锌邪褉邪褌邪

    袦袝袞袛校袧袗袪袨袛袧蝎袝 袩袨袛啸袨袛蝎 袣 袪袝袚校袥袠袪袨袙袗袧袠挟 袩袪袝袩袗袪袗孝袨袙 袣袥袝孝袨效袧袨袡 孝袝袪袗袩袠袠

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    This article is a review of the main methods and approaches used in regulation of cell therapy products in the United States of America, Canada, European Union, Australia, Japan and South Korea. Intensive developments of scientific and technological aspects in stem cell and tissue engineering have led to the wide use of human cells and tissues for the treatment of various diseases and injuries of organs and tissues. Drug regulatory agencies of different countries are working on implementation of a risk-based legal framework with some common features. In many countries there is a multilevel control system that assures quality and safety of used聽 cell products. Competent authorities establish strict requirements聽 both to safety of the products and to the implemented standards of good laboratory, manufacturing, clinical and tissue practices.聽聽聽袙 芯斜蟹芯褉械 芯锌懈褋邪薪褘 芯褋薪芯胁薪褘械 屑械卸写褍薪邪褉芯写薪褘械 锌芯写褏芯写褘 懈 薪邪锌褉邪胁谢械薪懈褟 薪芯褉屑邪褌懈胁薪芯谐芯 褉械谐褍谢懈褉芯胁邪薪懈褟 锌褉械锌邪褉邪褌芯胁 泻谢械褌芯褔薪芯泄 褌械褉邪锌懈懈 胁 小楔袗, 袣邪薪邪写械, 袝胁褉芯锌械, 袗胁褋褌褉邪谢懈懈, 携锌芯薪懈懈 懈 挟卸薪芯泄 袣芯褉械械. 袠薪褌械薪褋懈胁薪芯械 薪邪褍褔薪芯-褌械褏薪芯谢芯谐懈褔械褋泻芯械 褉邪蟹胁懈褌懈械 泻谢械褌芯褔薪芯泄 懈 褌泻邪薪械胁芯泄 懈薪卸械薪械褉懈懈 锌褉懈胁械谢芯 泻 邪泻褌懈胁薪芯屑褍 懈褋锌芯谢褜蟹芯胁邪薪懈褞 褔械谢芯胁械褔械褋泻懈褏 泻谢械褌芯泻 懈 褌泻邪薪械泄 写谢褟 谢械褔械薪懈褟 褉邪蟹谢懈褔薪褘褏 蟹邪斜芯谢械胁邪薪懈泄 懈 泻芯屑斜懈薪懈褉芯胁邪薪薪褘褏 锌芯胁褉械卸写械薪懈泄. 袪械谐褍谢褟褌芯褉薪褘械 芯褉谐邪薪褘 褉邪蟹薪褘褏 褋褌褉邪薪 褉邪斜芯褌邪褞褌 薪邪写 褍褋褌邪薪芯胁谢械薪懈械屑 薪芯褉屑邪褌懈胁薪芯-锌褉邪胁芯胁芯泄 斜邪蟹褘, 芯褋薪芯胁邪薪薪芯泄 薪邪 芯褑械薪泻械 褉懈褋泻芯胁, 褋 薪械泻芯褌芯褉褘屑懈芯斜褖懈屑懈 褔械褉褌邪屑懈. 袙 褉褟写械 褋褌褉邪薪 屑懈褉邪 懈屑械械褌褋褟 屑薪芯谐芯褋褌褍锌械薪褔邪褌邪褟 褋懈褋褌械屑邪 泻芯薪褌褉芯谢褟, 谐邪褉邪薪褌懈褉褍褞褖邪褟 泻邪褔械褋褌胁芯 懈 斜械蟹芯锌邪褋薪芯褋褌褜 锌褉懈屑械薪械薪懈褟 泻谢械褌芯褔薪芯谐芯 锌褉芯写褍泻褌邪. 袚芯褋褍写邪褉褋褌胁械薪薪褘械 褉械谐褍谢褟褌芯褉薪褘械 芯褉谐邪薪褘 锌褉械写褗褟胁谢褟褞褌 卸械褋褌泻懈械 褌褉械斜芯胁邪薪懈褟 薪械 褌芯谢褜泻芯 泻 斜械蟹芯锌邪褋薪芯褋褌懈 褋邪屑芯泄 锌褉芯写褍泻褑懈懈, 薪芯 懈 泻 褋褌邪薪写邪褉褌邪屑 芯褋褍褖械褋褌胁谢械薪懈褟 薪邪写谢械卸邪褖械泄 谢邪斜芯褉邪褌芯褉薪芯泄, 锌褉芯懈蟹胁芯写褋褌胁械薪薪芯泄, 泻谢懈薪懈褔械褋泻芯泄 懈 褌泻邪薪械胁芯泄 锌褉邪泻褌懈泻懈
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