Approaches to clinical development of combination medicines in the Russian Federation and the Eurasian Economic Union in view of the requirements of the current legislation
In recent years, there has been an increasing interest in the development of combination medicines (fixed drug combinations) containing two or more active ingredients in a single dosage form. Therefore, there is an urgent need to develop an optimal programme of pre-authorisation clinical trials for...
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| Format: | Article |
| Language: | Russian |
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Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)
2019-03-01
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| Series: | Регуляторные исследования и экспертиза лекарственных средств |
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| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/208 |
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| _version_ | 1849393976440782848 |
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| author | A. V. Dobrovolskiy |
| author_facet | A. V. Dobrovolskiy |
| author_sort | A. V. Dobrovolskiy |
| collection | DOAJ |
| description | In recent years, there has been an increasing interest in the development of combination medicines (fixed drug combinations) containing two or more active ingredients in a single dosage form. Therefore, there is an urgent need to develop an optimal programme of pre-authorisation clinical trials for combination medicines. The aim of the paper was to summarise modern science-based approaches to clinical development of combination medicines and identify possible ways of their practical implementation, taking into account the requirements of the current legislation. The author reviewed scientific publications devoted to creation of fixed drug combinations and analysed the regulatory documents defining regulatory requirements for pre-authorisation clinical studies of medicines in the Eurasian Economic Union, the Russian Federation, and other countries. Based on the results of the analysis the author described the general regulatory requirements for planning clinical studies of combination medicines for the purpose of their subsequent authorisation in the Russian Federation (via the national procedure) and the Eurasian Economic Union (via the centralized procedure). The pre-authorisation clinical development programme should be designed individually for each combination medicine. The selection of an optimal clinical trial strategy will make it possible to obtain sufficient information on the efficacy and safety of a combination medicine for its subsequent authorisation. |
| format | Article |
| id | doaj-art-ab81f41dad254f6998810cb211f7d072 |
| institution | Kabale University |
| issn | 3034-3062 3034-3453 |
| language | Russian |
| publishDate | 2019-03-01 |
| publisher | Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) |
| record_format | Article |
| series | Регуляторные исследования и экспертиза лекарственных средств |
| spelling | doaj-art-ab81f41dad254f6998810cb211f7d0722025-08-20T03:40:14ZrusFederal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)Регуляторные исследования и экспертиза лекарственных средств3034-30623034-34532019-03-0191142710.30895/1991-2919-2019-9-1-14-27184Approaches to clinical development of combination medicines in the Russian Federation and the Eurasian Economic Union in view of the requirements of the current legislationA. V. Dobrovolskiy0Scientific Centre for Expert Evaluation of Medicinal ProductsIn recent years, there has been an increasing interest in the development of combination medicines (fixed drug combinations) containing two or more active ingredients in a single dosage form. Therefore, there is an urgent need to develop an optimal programme of pre-authorisation clinical trials for combination medicines. The aim of the paper was to summarise modern science-based approaches to clinical development of combination medicines and identify possible ways of their practical implementation, taking into account the requirements of the current legislation. The author reviewed scientific publications devoted to creation of fixed drug combinations and analysed the regulatory documents defining regulatory requirements for pre-authorisation clinical studies of medicines in the Eurasian Economic Union, the Russian Federation, and other countries. Based on the results of the analysis the author described the general regulatory requirements for planning clinical studies of combination medicines for the purpose of their subsequent authorisation in the Russian Federation (via the national procedure) and the Eurasian Economic Union (via the centralized procedure). The pre-authorisation clinical development programme should be designed individually for each combination medicine. The selection of an optimal clinical trial strategy will make it possible to obtain sufficient information on the efficacy and safety of a combination medicine for its subsequent authorisation.https://www.vedomostincesmp.ru/jour/article/view/208combination medicinesfixed drug combinationclinical developmentclinical trialauthorisation of medicinesregulatory requirements |
| spellingShingle | A. V. Dobrovolskiy Approaches to clinical development of combination medicines in the Russian Federation and the Eurasian Economic Union in view of the requirements of the current legislation Регуляторные исследования и экспертиза лекарственных средств combination medicines fixed drug combination clinical development clinical trial authorisation of medicines regulatory requirements |
| title | Approaches to clinical development of combination medicines in the Russian Federation and the Eurasian Economic Union in view of the requirements of the current legislation |
| title_full | Approaches to clinical development of combination medicines in the Russian Federation and the Eurasian Economic Union in view of the requirements of the current legislation |
| title_fullStr | Approaches to clinical development of combination medicines in the Russian Federation and the Eurasian Economic Union in view of the requirements of the current legislation |
| title_full_unstemmed | Approaches to clinical development of combination medicines in the Russian Federation and the Eurasian Economic Union in view of the requirements of the current legislation |
| title_short | Approaches to clinical development of combination medicines in the Russian Federation and the Eurasian Economic Union in view of the requirements of the current legislation |
| title_sort | approaches to clinical development of combination medicines in the russian federation and the eurasian economic union in view of the requirements of the current legislation |
| topic | combination medicines fixed drug combination clinical development clinical trial authorisation of medicines regulatory requirements |
| url | https://www.vedomostincesmp.ru/jour/article/view/208 |
| work_keys_str_mv | AT avdobrovolskiy approachestoclinicaldevelopmentofcombinationmedicinesintherussianfederationandtheeurasianeconomicunioninviewoftherequirementsofthecurrentlegislation |