Pharmacovigilance System Master File: An Overview of Changes in the EAEU Good Pharmacovigilance Practice
The development of international regulatory practices and the accumulation of new experience in pharmacovigilance prompted the need to amend the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union (EAEU GVP Guideline), first adopted in 2016.The aim of the study was to review, fr...
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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/350 |
| _version_ | 1797224543161417728 |
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| author | N. Yu. Velts E. O. Zhuravleva G. V. Kutekhova N. V. Tereshkina |
| author_facet | N. Yu. Velts E. O. Zhuravleva G. V. Kutekhova N. V. Tereshkina |
| author_sort | N. Yu. Velts |
| collection | DOAJ |
| description | The development of international regulatory practices and the accumulation of new experience in pharmacovigilance prompted the need to amend the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union (EAEU GVP Guideline), first adopted in 2016.The aim of the study was to review, from a regulatory expert’s perspective, the changes to the structure and presentation of the pharmacovigilance system master file (PSMF) introduced with the amendment of the EAEU GVP Guideline effective since December 6, 2022.The authors compared the requirements for the PSMF outlined in the new edition of the EAEU GVP Guideline adopted by Decision No.81 of the Council of the Eurasian Economic Commission of 19.06.2022 “On Amendments to the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union” with the requirements described in the previous version of this document.The structure and content of Module III, Pharmacovigilance System Master File, have been significantly amended in the new version of the EAEU GVP Guideline; this will require marketing authorisation holders (MAHs) to revise the PSMFs describing pharmacovigilance system data. The most significant editorial changes have been made to the paragraphs concerning the PSMF format, the pharmacovigilance quality system, and the presentation of information in the Annexes. The amendment has strengthened the control of records and documentation related to the pharmacovigilance system. Electronic PSMFs are acceptable; electronic book-marking and searchable text make working with the PSMF more convenient for representatives of MAHs and experts of regulatory authorities. Aligning of the PSMF with the requirements of the new edition of the EAEU GVP Guideline will contribute to improving the pharmacovigilance system operation and performance. |
| first_indexed | 2024-03-08T22:26:30Z |
| format | Article |
| id | doaj.art-8685ecadd6b14595844ddc25f7bbee54 |
| institution | Directory Open Access Journal |
| issn | 2312-7821 2619-1164 |
| language | Russian |
| last_indexed | 2024-04-24T13:54:47Z |
| 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-8685ecadd6b14595844ddc25f7bbee542024-04-03T17:56:38ZrusMinistry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Безопасность и риск фармакотерапии2312-78212619-11642023-03-01111222910.30895/2312-7821-2023-11-1-22-29284Pharmacovigilance System Master File: An Overview of Changes in the EAEU Good Pharmacovigilance PracticeN. Yu. Velts0E. O. Zhuravleva1G. V. Kutekhova2N. V. Tereshkina3Scientific 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 ProductsThe development of international regulatory practices and the accumulation of new experience in pharmacovigilance prompted the need to amend the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union (EAEU GVP Guideline), first adopted in 2016.The aim of the study was to review, from a regulatory expert’s perspective, the changes to the structure and presentation of the pharmacovigilance system master file (PSMF) introduced with the amendment of the EAEU GVP Guideline effective since December 6, 2022.The authors compared the requirements for the PSMF outlined in the new edition of the EAEU GVP Guideline adopted by Decision No.81 of the Council of the Eurasian Economic Commission of 19.06.2022 “On Amendments to the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union” with the requirements described in the previous version of this document.The structure and content of Module III, Pharmacovigilance System Master File, have been significantly amended in the new version of the EAEU GVP Guideline; this will require marketing authorisation holders (MAHs) to revise the PSMFs describing pharmacovigilance system data. The most significant editorial changes have been made to the paragraphs concerning the PSMF format, the pharmacovigilance quality system, and the presentation of information in the Annexes. The amendment has strengthened the control of records and documentation related to the pharmacovigilance system. Electronic PSMFs are acceptable; electronic book-marking and searchable text make working with the PSMF more convenient for representatives of MAHs and experts of regulatory authorities. Aligning of the PSMF with the requirements of the new edition of the EAEU GVP Guideline will contribute to improving the pharmacovigilance system operation and performance.https://www.risksafety.ru/jour/article/view/350good pharmacovigilance practice of the eurasian economic uniongvppharmacovigilancepharmacovigilance systempharmacovigilance system master filemarketing authorisation of medicinesregulatory assessment of medicines |
| spellingShingle | N. Yu. Velts E. O. Zhuravleva G. V. Kutekhova N. V. Tereshkina Pharmacovigilance System Master File: An Overview of Changes in the EAEU Good Pharmacovigilance Practice Безопасность и риск фармакотерапии good pharmacovigilance practice of the eurasian economic union gvp pharmacovigilance pharmacovigilance system pharmacovigilance system master file marketing authorisation of medicines regulatory assessment of medicines |
| title | Pharmacovigilance System Master File: An Overview of Changes in the EAEU Good Pharmacovigilance Practice |
| title_full | Pharmacovigilance System Master File: An Overview of Changes in the EAEU Good Pharmacovigilance Practice |
| title_fullStr | Pharmacovigilance System Master File: An Overview of Changes in the EAEU Good Pharmacovigilance Practice |
| title_full_unstemmed | Pharmacovigilance System Master File: An Overview of Changes in the EAEU Good Pharmacovigilance Practice |
| title_short | Pharmacovigilance System Master File: An Overview of Changes in the EAEU Good Pharmacovigilance Practice |
| title_sort | pharmacovigilance system master file an overview of changes in the eaeu good pharmacovigilance practice |
| topic | good pharmacovigilance practice of the eurasian economic union gvp pharmacovigilance pharmacovigilance system pharmacovigilance system master file marketing authorisation of medicines regulatory assessment of medicines |
| url | https://www.risksafety.ru/jour/article/view/350 |
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