Periodic Benefit–Risk Evaluation Report: A Review of Changes
A periodic benefit–risk evaluation report (PBRER) is a retrospective evaluation document enabling marketing authorisation holders to present the results of a critical analysis of the benefit–risk ratio of a medicinal product. PBRER submission and content requirements changed with the adoption of the...
| 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»
2023-03-01
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| Series: | Безопасность и риск фармакотерапии |
| Subjects: | |
| Online Access: | https://www.risksafety.ru/jour/article/view/357 |
| _version_ | 1797224549383667712 |
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| author | A. R. Titova N. V. Kosyakina T. S. Polikarpova Yu. S. Skorodumova V. A. Polivanov K. V. Gorelov |
| author_facet | A. R. Titova N. V. Kosyakina T. S. Polikarpova Yu. S. Skorodumova V. A. Polivanov K. V. Gorelov |
| author_sort | A. R. Titova |
| collection | DOAJ |
| description | A periodic benefit–risk evaluation report (PBRER) is a retrospective evaluation document enabling marketing authorisation holders to present the results of a critical analysis of the benefit–risk ratio of a medicinal product. PBRER submission and content requirements changed with the adoption of the second edition of the Guideline on Good Pharmacovigilance Practice of the Eurasian Economic Union (EAEU GVP Guideline) in 2022.The aim of the study was to analyse the changes to the EAEU GVP Guideline requirements for the submission procedure and the content of PBRERs.The authors analysed the main changes concerning the procedure for submitting PBRERs on multi-source and well-established medicinal products, herbal and homoeopathic medicines. The authors evaluated the updated requirements for the content of PBRER sections. The analysis identified no significant changes in the aim and concept of PBRERs.The results of the analysis described in this article will help marketing authorisation holders improve the quality of PBRERs and ensure compliance with the new requirements of the EAEU GVP Guideline. |
| first_indexed | 2024-03-08T22:26:35Z |
| format | Article |
| id | doaj.art-a05cd00c0c6540c6a68c6cc1f18366a7 |
| institution | Directory Open Access Journal |
| issn | 2312-7821 2619-1164 |
| language | Russian |
| last_indexed | 2024-04-24T13:54:53Z |
| publishDate | 2023-03-01 |
| publisher | Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Безопасность и риск фармакотерапии |
| spelling | doaj.art-a05cd00c0c6540c6a68c6cc1f18366a72024-04-03T17:56:38ZrusMinistry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Безопасность и риск фармакотерапии2312-78212619-11642023-03-01111465110.30895/2312-7821-2023-11-1-46-51281Periodic Benefit–Risk Evaluation Report: A Review of ChangesA. R. Titova0N. V. Kosyakina1T. S. Polikarpova2Yu. S. Skorodumova3V. A. Polivanov4K. V. Gorelov5Information and Methodological Center for Expert Evaluation, Recording and Analysis of Circulation of Medical Products of RoszdravnadzorInformation and Methodological Center for Expert Evaluation, Recording and Analysis of Circulation of Medical Products of RoszdravnadzorInformation and Methodological Center for Expert Evaluation, Recording and Analysis of Circulation of Medical Products of RoszdravnadzorInformation and Methodological Center for Expert Evaluation, Recording and Analysis of Circulation of Medical Products of RoszdravnadzorInformation and Methodological Center for Expert Evaluation, Recording and Analysis of Circulation of Medical Products of RoszdravnadzorFederal Service for Surveillance in Healthcare (Roszdravnadzor)A periodic benefit–risk evaluation report (PBRER) is a retrospective evaluation document enabling marketing authorisation holders to present the results of a critical analysis of the benefit–risk ratio of a medicinal product. PBRER submission and content requirements changed with the adoption of the second edition of the Guideline on Good Pharmacovigilance Practice of the Eurasian Economic Union (EAEU GVP Guideline) in 2022.The aim of the study was to analyse the changes to the EAEU GVP Guideline requirements for the submission procedure and the content of PBRERs.The authors analysed the main changes concerning the procedure for submitting PBRERs on multi-source and well-established medicinal products, herbal and homoeopathic medicines. The authors evaluated the updated requirements for the content of PBRER sections. The analysis identified no significant changes in the aim and concept of PBRERs.The results of the analysis described in this article will help marketing authorisation holders improve the quality of PBRERs and ensure compliance with the new requirements of the EAEU GVP Guideline.https://www.risksafety.ru/jour/article/view/357pharmacovigilancemedicinal productperiodic benefit–risk evaluation reportpbrermarketing authorisation holdergood pharmacovigilance practiceperiodic safety update reportpsur |
| spellingShingle | A. R. Titova N. V. Kosyakina T. S. Polikarpova Yu. S. Skorodumova V. A. Polivanov K. V. Gorelov Periodic Benefit–Risk Evaluation Report: A Review of Changes Безопасность и риск фармакотерапии pharmacovigilance medicinal product periodic benefit–risk evaluation report pbrer marketing authorisation holder good pharmacovigilance practice periodic safety update report psur |
| title | Periodic Benefit–Risk Evaluation Report: A Review of Changes |
| title_full | Periodic Benefit–Risk Evaluation Report: A Review of Changes |
| title_fullStr | Periodic Benefit–Risk Evaluation Report: A Review of Changes |
| title_full_unstemmed | Periodic Benefit–Risk Evaluation Report: A Review of Changes |
| title_short | Periodic Benefit–Risk Evaluation Report: A Review of Changes |
| title_sort | periodic benefit risk evaluation report a review of changes |
| topic | pharmacovigilance medicinal product periodic benefit–risk evaluation report pbrer marketing authorisation holder good pharmacovigilance practice periodic safety update report psur |
| url | https://www.risksafety.ru/jour/article/view/357 |
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