Standard form of a periodic safety update report
Abstract
The results of evaluating information in the Periodic safety update reports (PSUR) submitted by marketing-authorisation holder indicate a lack of understanding of regulatory requirements for the preparation of this document. As a result PSURs submitted by some marketing authorisation holders are returned to them for correction. The purpose of this article is to present the standard forms of PSUR, which will allow you to adequately prepare this reporting document.
Keywords
периодический отчет по безопасности (ПОБ),
периодический обновляемый отчет по безопасности (ПООБ),
периодический отчет по безопасности лекарственного средства (ПОБЛС),
периодический отчет по безопасности лекарственного препарата (ПОБЛП),
шаблон,
Periodic safety update reports (PSUR),
standard forms
About the Authors
B. R. Romanov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
R. N. Alyautdin
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
M. A. Darmostukova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
S. V. Glagolev
Federal Service for Surveillance in Healthcare
Russian Federation
Russian Federation
V. A. Polivanov
Information and Methodological Centre for Expert Evaluation, Recording and Analysis of Circulation of Medicinal Products
Russian Federation
Russian Federation
References
1. Order of Roszdravnadzor of 15.02.2017 ¹ 1071 «On approval of the Procedure of pharmacovigilance». [Internet]. 2017 [cited 2017 Oct 4]. Available from: http://www.roszdravnadzor.ru/documents/39003 (in Russian).
2. The decision of the Board Eurasian economic Commission of 3.11.2016–87 «About approval of Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union». [Internet]. 2017. [cited 2017 Oct 4]. Available from: http://docs.eaeunion.org/docs/ru-ru/01411948/cncd_21112016_87 (in Russian).
3. Snegireva II, Zatolochina KE, Ozeretskovsky NA, Romanov BK, Mironov AN. Vaccine pharmacovigilance in Russia, legal and regulatory framework, current stage of development. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 2014; (4): 27–31 (in Russian).
Review
For citations:
Romanov B.R., Alyautdin R.N., Darmostukova M.A., Glagolev S.V., Polivanov V.A. Standard form of a periodic safety update report. Safety and Risk of Pharmacotherapy. 2017;5(4):148-160. (In Russ.)
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