José Antonio García Erce: EMA Certifies Plasma from Egypt for EU Use for the First Time
José Antonio García Erce, Director of the Donation Center, Navarre Health Service (Osasunbidea), posted on LinkedIn:
“THE EMA CERTIFIES PLASMA FROM AFRICA AND THE MIDDLE EAST FOR THE FIRST TIME TO MANUFACTURE BLOOD PRODUCTS IN THE EU
Note from today’s Agencia Española de Medicamentos y Productos Sanitarios (AEMPS):
“Egypt has become the first country in the region to have a plasma collection and processing system aligned with the most demanding EU regulatory standards.
The AEMPS has been in charge of coordinating this certification that will mean that this plasma can be imported for the subsequent manufacture of blood products in European territory.
This certification thus contributes to a more diversified, safe and resilient supply chain that will guarantee that Spanish and European patients continue to have access to essential therapies, under the highest levels of quality, safety and efficacy.”
This has been a success for the Spanish company Grifols, which through Grifols Egypt for Plasma Derivatives (GEPD), would have first achieved clinical self-sufficiency in inmunoglobulins, albumins and coagulation factors for bleeding disorders in Egypt, and will now allow them to export their plasma-derived medicines likely from “reasonably compensated” or “presumably partially remunerated” donates to treat patients from European countries that are not self-sufficient. with its current model.
Hopefully, in other countries in Africa or Latin America, successful strategies like this can be developed to be able to give access to these critical and essential products to the general population of these countries with fewer resources, for equity and justice.”
Get more information below:
“La EMA certifica por primera vez plasma procedente de África y Oriente Medio para fabricar hemoderivados en la UE”
“Medicamentos hemoderivados”
“Egypt achieves self-sufficiency in plasma-derived medicines thanks to Grifols”
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