vedomostiregmedРегуляторные исследования и экспертиза лекарственных средствRegulatory Research and Medicine Evaluation3034-30623034-3453Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)vedomostiregmed-58Research ArticleЭКСПЕРТИЗА ЛЕКАРСТВЕННЫХ СРЕДСТВEXPERT EVALUATION OF MEDICINESОпыт российского и зарубежного законодательства в области регулирования внесения пострегистрационных изменений в досье на лекарственные препаратыRussian and foreign legislation on regulation of post approval variations in the dossier for the medicinal productsОлефирЮ. В.OlefirYu. V.noemail@neicon.ruМеркуловВ. А.MerkulovV. A.noemail@neicon.ruСоловьевЕ. А.SolovievE. A.noemail@neicon.ruУстюговаЕ. А.UstyugovaE. A.ustugova@expmed.ruСаяпинаЛ. В.SayapinaL. V.noemail@neicon.ruБондаревВ. П.BondarevV. P.noemail@neicon.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationRussian Federation201513022018041115Copyright © Олефир Ю.В., Меркулов В.А., Соловьев Е.А., Устюгова Е.А., Саяпина Л.В., Бондарев В.П., 20182018Олефир Ю.В., Меркулов В.А., Соловьев Е.А., Устюгова Е.А., Саяпина Л.В., Бондарев В.П.Olefir Y.V., Merkulov V.A., Soloviev E.A., Ustyugova E.A., Sayapina L.V., Bondarev V.P.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.vedomostincesmp.ru/jour/article/view/58

Регистрация лекарственных препаратов является важным звеном в регулировании рынка лекарственных средств. Быстрое развитие фармацевтической промышленности, включая появление новых данных о применении лекарств, изменение их состава и усовершенствование методов контроля качества, создает необходимость внесения изменений в исходное регистрационное досье. Процедура одобрения таких изменений играет решающую роль в появлении на рынке лекарственных средств с улучшенными фармакологическими свойствами. Действенный и прозрачный процесс принятия решений о внесении пострегистрационных изменений призван усилить стремление производителей непрерывно улучшать свойства препаратов. В данной статье рассмотрены особенности нормативной базы, касающиеся внесения пострегистрационных изменений в досье, принятые в странах Европейского Союза, США и России. Кроме этого затронут вопрос предстоящих изменений в этой сфере в Российской Федерации как в связи с созданием Евразийского экономического союза (ЕАЭС), так и в связи с необходимостью гармонизации процедур регулирования обращения лекарственных средств со странами Европейского Союза (ЕС).

Drug licensing is the most crucial factor for effective market regulation of pharmaceuticals. The rapid development of the pharmaceutical industry, emergence of new scientific data, and changes in composition of medicinal products drive the need for introduction of variations in original registration dossiers. The process of such variation approval implemented in a particular country is the key factor in assessing the effects of the variation on the quality, safety and efficacy of the medicinal product, and sets a timelines for their realization. The present article describes existing classifications of variations, which are adopted in the European Union (EU), USA and Russia. Also the article concerns the upcoming changes in Russia in the scope of Eurasian Economic Union establishment and the necessity of harmonizing the procedure with the European Union.

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The authors declare that there are no conflicts of interest present.