Authorization of Vaccines in the European Union

Autor:	Radu Botgros, Ana Hidalgo-Simon, Emil Cochino
Rok vydání:	2021
Předmět:	business.industry Authorization media_common.cataloged_instance Business International trade European union media_common
Zdroj:	Molecular Frontiers Journal. :58-65
ISSN:	2529-7333 2529-7325
DOI:	10.1142/s2529732521400034
Popis:	The current COVID-19 pandemic has had a vertiginous accelerating effect on the time from identification of a new virus to a vaccine being deployed. A key step in this journey, the marketing authorization process, is under intense scrutiny and time pressure. The marketing authorization is a necessary gateway that protects public health and provides healthcare professionals and the general public with reliable and relevant evidence reflected in the product information to allow the safe and effective use of these vaccines. Regulators have the expertise and the duty to evaluate vaccines’ benefits and risks and, importantly, monitor safety during clinical use. This evaluation is more important than ever during a pandemic—and must be allowed to be as thorough as ever.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::566233d9f8b4b81ef9ff3cfa1d73230d https://doi.org/10.1142/s2529732521400034 Zobrazit plný text záznamu