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| http://dx.doi.org/10.18773/austprescr.2018.010 | DOI Listing |
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Generic Drugs and the Struggle to Compete: The Role of Skinny Labels.
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Department of Public Health and Community Medicine, Tufts University School of Medicine, Boston, Massachusetts.
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Medicines Evaluation Board, Utrecht, The Netherlands.
The European Union (EU) regulatory network was at the forefront of the safety monitoring of COVID-19 vaccines during the pandemic. An unprecedented number of case reports of suspected adverse reactions after vaccination called for huge efforts for the assessment of this safety information, to ensure that any possible risks were detected and managed as early as possible, while ruling out coincidental but temporally related adverse health outcomes. We describe the role of the European Medicines Agency alongside the EU regulatory network in the safety monitoring of the COVID-19 vaccines, and provide an insight into challenges, particularities and outcomes of the scientific assessment and regulatory decisions in the complex, dynamic international environment of the pandemic.
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Pharmacovigilance Department, Laboratorios Sophia, S.A. de C.V., Av. Paseo del Norte 5255, Zapopan, Jalisco 45010, México.
To perform optimal monitoring of the safety profile in the postmarketing phase, Marketing Authorization Holders and National Regulatory Authorities (NRAs) must evaluate the adverse drug reactions (ADRs) that occurred and characterize their nature, frequency, and severity. Management is possible through Individual Case Safety Reports (ICSRs), which are the reports of organized and processed data. Globally, the International Council for Harmonisation (ICH) E2B guideline suggests harmonized activities for the ICSR electronic content and transmission.
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