Preview

Safety and Risk of Pharmacotherapy

Advanced search

Pharmacovigilance System Master File: An Overview of Changes in the EAEU Good Pharmacovigilance Practice

https://doi.org/10.30895/2312-7821-2023-11-1-22-29

Abstract

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.

About the Authors

N. Yu. Velts
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Nataliya Yu. Velts, Cand. Sci. (Biol.), Associate Professor

127051, Moscow, Petrovsky Blvd, 8/2



E. O. Zhuravleva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Evgeniya O. Zhuravleva

127051, Moscow, Petrovsky Blvd, 8/2



G. V. Kutekhova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Galina V. Kutekhova

127051, Moscow, Petrovsky Blvd, 8/2



N. V. Tereshkina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Nataliya V. Tereshkina, Cand. Sci. (Med.)

127051, Moscow, Petrovsky Blvd, 8/2



References

1. Peters T, Soanes N, Abbas M, Ahmad J, Delumeau JC, Herrero-Martinez E, et al. Effective pharmacovigilance system development: EFPIA-IPVG consensus recommendations. Drug Saf. 2021;44(1):17–28. https://doi.org/10.1007/s40264-020-01008-0

2. Lavery C, Emmott J, Jeck-Thole S, Rouben P, Usher D, van der Spuij W, Woodward L. An industry survey on managing the pharmacovigilance system master file in a global environment: the need for a pragmatic approach. Pharmaceut Med. 2022;36(4):233–45. https://doi.org/10.1007/s40290-022-00422-2

3. Rocca E, Copeland S, Ralph Edwards I. Pharmacovigilance as scientific discovery: an argument for trans-disciplinarity. Drug Saf. 2019;42(10): 1115–24. https://doi.org/10.1007/s40264-019-00826-1

4. Santoro A, Genov G, Spooner A, Raine J, Arlett P. Promoting and protecting public health: how the European Union pharmacovigilance system works. Drug Saf. 2017;40(10):855–69. https://doi.org/10.1007/s40264-017-0572-8

5. Gildeeva GN, Belostotsky AV. Recent changes in the pharmacovigilance system in the Russian Federation and the EAEU. PHARMACOECONOMICS. Mo­dern Pharmacoeconomics and Pharmacoepidemiology. 2019;12(2):86–90 (In Russ.). https://doi.org/10.17749/2070-4909.2019.12.2.86-90

6. Glagolev SV, Gorelov KV, Chizhova DA. Russian pharmacovigilance in a newly regulated environment: two-year results and prospects. Remedium. 2019;(3):8–14 (In Russ.). https://doi.org/10.21518/1561-5936-2019-3-8-14

7. Taube AA, Evko IYu, Sinotova SV, Krasheninnikov AE, Zhuravleva MV, Romanov BK, Alyautdin RN. Russian pharmacovigilance: ways to improve efficiency. Bulletin of the Russian Military Medical Academy. 2019;(3):8–14 (In Russ.). https://doi.org/10.17816/brmma89665

8. Taube AA, Levashova AYu. Bringing the registration dossier for a medicinal product in line with the requirements of the Eurasian Economic Union. Journal of Pharmaceuticals Quality Assurance Issues. 2020;2(28):40–7 (In Russ.). https://doi.org/10.34907/JPQAI.2020.22.25.006


Supplementary files

Review

For citations:


Velts N.Yu., Zhuravleva E.O., Kutekhova G.V., Tereshkina N.V. Pharmacovigilance System Master File: An Overview of Changes in the EAEU Good Pharmacovigilance Practice. Safety and Risk of Pharmacotherapy. 2023;11(1):22-29. (In Russ.) https://doi.org/10.30895/2312-7821-2023-11-1-22-29

Views: 1761


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2312-7821 (Print)
ISSN 2619-1164 (Online)