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EMA and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) have signed a working arrangement with the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea for the exchange of confidential information on medical and medicinal products.
NewsCorporate
EMA has published a number of recommendations to address vulnerabilities in the production and delivery of medicines included in the Union list of critical medicines and strengthen their supply chain.
NewsHumanMedicine shortages
Report on COVID-19 vaccine strain updates: global regulators agree on timing and data requirements
NewsHumanMedicinesVaccines
GLP-1 receptor agonists: available evidence not supporting link with suicidal and self-injurious thoughts and actions
NewsHumanMedicinesPharmacovigilanceReferrals
Due to planned system maintenance, several EMA applications will be fully or partially inaccessible from 11 to 17 April.
NewsCorporate
The European Medicines Agency (EMA) reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on 1 April 2024.
NewsCorporate
The European Medicines Agency's (EMA) office is closed from 18:30 on Wednesday 27 March 2024 to 07:30 on Tuesday 2 April 2024.
NewsCorporate
Outcomes of the EMA Management Board meeting. The Management Board is an integral governance body of the Agency.
NewsHumanCorporateClinical trialsFees
EMA has recommended granting a marketing authorisation in the European Union (EU) for Emblaveo (aztreonam-avibactam), indicated for the treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by certain types of bacteria (aerobic Gram-negative) where treatment options are limited.
NewsHumanMedicines
EMA has recommended granting a marketing authorisation in the European Union (EU) for Fabhalta (iptacopan), an oral treatment for adults with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia.
NewsHumanMedicines