EMA recommends expanded compassionate use of COVID-19 drug remdesivir
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding compassionate use of the investigational … read more »
EU meeting discusses measures to address ICU medicines shortages during COVID-19
In a virtual meeting held on 6th May, the EU Executive Steering Group on Shortages of Medicines Caused by Major … read more »
EMA begins initial licensing process for remdesivir under emergency procedures
In light of recent positive indicators around remdesivir for the treatment of COVID-19, the EMA has begun conducting review of … read more »
Analysis of EMA Q&A for medicinal products during the COVID-19 pandemic
MAP has been provided with an analysis of the EMA COVID-19 Q&A reported on recently. The European Commission recently published … read more »
NIH announces public-private partnership against COVID-19
The US National Institutes of Health (NIH) and Foundation for the NIH (FNIH) have launched a collaboration between industry and … read more »
EMA published Q&A on coronavirus regulatory requirements
In order to better explain the flexibilities introduced to manage the coronavirus pandemic, the European Commission (EC), European Medicines Agency … read more »
Coronavirus triggers medicine shortages and restrictions
The European Medicines Agency (EMA) is reporting shortages of certain medicines in certain Member States. Bodies such as the UK’s … read more »
EMA publishes Regulatory Science Strategy to 2025
The European Medicines Agency (EMA) has launched its Regulatory Science Strategy to 2025 to ensure its regulatory work is optimised … read more »
Clinical Trials: Letter from the SME office of the EMA
The Small and Medium-sized Enterprises (SME) office of the European Medicines Agency (EMA) has written to stakeholders on the situation … read more »
EMA activates plans for health threats to support coronavirus work
The European Medicines Agency (EMA) has activated its plan for managing emerging health threats to support manufacturers of vaccines and … read more »
