New regulatory strategies aimed to minimize shortages of essential generic/biosimilar medicines in Europe by simplifying the Regulatory Authority maintenance of MA licenses for essential generics to reduce fees and costs to the Marketing Authorization holder, improving the resilience of healthcare stakeholders to medicines shortages and setting economic sustainable and effective pharmaceutical quality systems throughout the pharmaceutical supply chain.
New regulatory strategies to support Regulatory Agencies/stakeholders in preventing shortages in Europe / U.M. Musazzi. ((Intervento presentato al convegno Workshop on scope and methodology of drug shortages research tenutosi a Krakow nel 2019.
New regulatory strategies to support Regulatory Agencies/stakeholders in preventing shortages in Europe
U.M. Musazzi
2019
Abstract
New regulatory strategies aimed to minimize shortages of essential generic/biosimilar medicines in Europe by simplifying the Regulatory Authority maintenance of MA licenses for essential generics to reduce fees and costs to the Marketing Authorization holder, improving the resilience of healthcare stakeholders to medicines shortages and setting economic sustainable and effective pharmaceutical quality systems throughout the pharmaceutical supply chain.
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