Current regulatory requirements for non-clinical evaluation of prophylactic vaccines
Vaccines are subject to specific regulatory requirements for the evaluation of their quality, safety, and efficacy. In 2005, the World Health Organisation (WHO), as the main international organisation coordinating measures to combat infectious disease outbreaks, began developing documents on the eva...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | Russian |
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Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2023-04-01
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| Series: | Биопрепараты: Профилактика, диагностика, лечение |
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| Online Access: | https://www.biopreparations.ru/jour/article/view/489 |
| _version_ | 1797244501903802368 |
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| author | D. V. Gorenkov E. I. Komarovskaya A. A. Soldatov Zh. I. Avdeeva V. P. Bondarev |
| author_facet | D. V. Gorenkov E. I. Komarovskaya A. A. Soldatov Zh. I. Avdeeva V. P. Bondarev |
| author_sort | D. V. Gorenkov |
| collection | DOAJ |
| description | Vaccines are subject to specific regulatory requirements for the evaluation of their quality, safety, and efficacy. In 2005, the World Health Organisation (WHO), as the main international organisation coordinating measures to combat infectious disease outbreaks, began developing documents on the evaluation of vaccine quality, safety, and efficacy. The world’s leading regulatory authorities (FDA, EMA, etc.) have also issued recommendations for conducting non-clinical studies of vaccines.The aim of this study was a critical review of the regulatory requirements established by foreign national and international regulatory authorities for non-clinical evaluation of the safety and efficacy of vaccines.According to the study results, since the 2000s, the WHO and the world’s leading regulatory authorities have produced more than 40 regulatory documents describing certain aspects of non-clinical studies of the safety and efficacy of vaccines. These documents can be divided into two groups: the first group addresses non-clinical studies of vaccines in general, and the second one dwells upon the evaluation of the quality, safety, and efficacy of specific types of vaccines. For the Russian guidelines on non-clinical evaluation of the quality, safety, and efficacy of immunobiologicals, the latest revision dates back to 2013 and does not provide any information on new medicinal products. Currently, work is underway to prepare the regulatory framework for medicines, including vaccines, in the Member States of the Eurasian Economic Union (EAEU). This review of regulatory documents on non-clinical safety and efficacy studies of vaccines may be useful in drafting harmonised guidelines for the relevant groups of vaccines in the EAEU. It may also be of use to developers, manufacturers, and researchers involved in the creation and non-clinical study of vaccines. |
| first_indexed | 2024-03-08T21:43:16Z |
| format | Article |
| id | doaj.art-a6ada49ddbeb4215b4a68527cc963ec7 |
| institution | Directory Open Access Journal |
| issn | 2221-996X 2619-1156 |
| language | Russian |
| last_indexed | 2024-04-24T19:12:01Z |
| publishDate | 2023-04-01 |
| publisher | Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Биопрепараты: Профилактика, диагностика, лечение |
| spelling | doaj.art-a6ada49ddbeb4215b4a68527cc963ec72024-03-26T09:10:54ZrusMinistry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Биопрепараты: Профилактика, диагностика, лечение2221-996X2619-11562023-04-0123172510.30895/2221-996X-2023-23-1-7-25317Current regulatory requirements for non-clinical evaluation of prophylactic vaccinesD. V. Gorenkov0E. I. Komarovskaya1A. A. Soldatov2Zh. I. Avdeeva3V. P. Bondarev4Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsVaccines are subject to specific regulatory requirements for the evaluation of their quality, safety, and efficacy. In 2005, the World Health Organisation (WHO), as the main international organisation coordinating measures to combat infectious disease outbreaks, began developing documents on the evaluation of vaccine quality, safety, and efficacy. The world’s leading regulatory authorities (FDA, EMA, etc.) have also issued recommendations for conducting non-clinical studies of vaccines.The aim of this study was a critical review of the regulatory requirements established by foreign national and international regulatory authorities for non-clinical evaluation of the safety and efficacy of vaccines.According to the study results, since the 2000s, the WHO and the world’s leading regulatory authorities have produced more than 40 regulatory documents describing certain aspects of non-clinical studies of the safety and efficacy of vaccines. These documents can be divided into two groups: the first group addresses non-clinical studies of vaccines in general, and the second one dwells upon the evaluation of the quality, safety, and efficacy of specific types of vaccines. For the Russian guidelines on non-clinical evaluation of the quality, safety, and efficacy of immunobiologicals, the latest revision dates back to 2013 and does not provide any information on new medicinal products. Currently, work is underway to prepare the regulatory framework for medicines, including vaccines, in the Member States of the Eurasian Economic Union (EAEU). This review of regulatory documents on non-clinical safety and efficacy studies of vaccines may be useful in drafting harmonised guidelines for the relevant groups of vaccines in the EAEU. It may also be of use to developers, manufacturers, and researchers involved in the creation and non-clinical study of vaccines.https://www.biopreparations.ru/jour/article/view/489vaccinesnon-clinical studiesvaccine developmentregulation |
| spellingShingle | D. V. Gorenkov E. I. Komarovskaya A. A. Soldatov Zh. I. Avdeeva V. P. Bondarev Current regulatory requirements for non-clinical evaluation of prophylactic vaccines Биопрепараты: Профилактика, диагностика, лечение vaccines non-clinical studies vaccine development regulation |
| title | Current regulatory requirements for non-clinical evaluation of prophylactic vaccines |
| title_full | Current regulatory requirements for non-clinical evaluation of prophylactic vaccines |
| title_fullStr | Current regulatory requirements for non-clinical evaluation of prophylactic vaccines |
| title_full_unstemmed | Current regulatory requirements for non-clinical evaluation of prophylactic vaccines |
| title_short | Current regulatory requirements for non-clinical evaluation of prophylactic vaccines |
| title_sort | current regulatory requirements for non clinical evaluation of prophylactic vaccines |
| topic | vaccines non-clinical studies vaccine development regulation |
| url | https://www.biopreparations.ru/jour/article/view/489 |
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