Post-approval variations to dossiers for vaccines: analysis of regulatory and methodological approaches used in the Russian Federation and abroad

Post-approval variations to dossiers for vaccines: analysis of regulatory and methodological approaches used in the Russian Federation and abroad

The management of post-approval changes to registration dossiers for medicinal products is one of the most important factors for ensuring sustainable quality, safety and efficacy of medicines. Competent authorities that use the module format of the registration dossier, i.e. the regulatory authoriti...

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Bibliographic Details
Main Authors: V. A. Shevtsov, Yu. V. Olefir, V. A. Merkulov, V. P. Bondarev, I. N. Indikova, E. E. Evreinova, A. V. Rukavishnikov, L. M. Khantimirova, D. V. Gorenkov
Format: Article
Language:Russian
Published: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2019-03-01
Series:Регуляторные исследования и экспертиза лекарственных средств
Subjects:
quality evaluation
quality standards
changes
variations
registration dossier
master-file
vaccine antigen
vaccine
Online Access:https://www.vedomostincesmp.ru/jour/article/view/171
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