EMA and FDA strengthen collaboration on medicines
The European Commission (EC), European Medicines Agency (EMA) and US Food and Drugs Administration (FDA) have agreed new priorities in … read more »
EMA removes scientific advice fees for some academic work
The European Medicines Agency (EMA) will work to encourage development of medicines for rare diseases by waiving the fees it … read more »
EMA launches 2019 annual report
The annual report of the European Medicines Agency (EMA) for 2019 has been released, giving insights into the work done … read more »
EMA encourages early discussions to improve evidence generation
The European Medicines Agency (EMA), in collaboration with other parties, has published two scientific articles encouraging early discussions between developers … read more »
Gene therapy Zolgensma granted conditional approval from the EMA
AveXis have been granted European conditional approval from the European Medicines Agency (EMA) for its spinal muscular atrophy (SMA) gene … read more »
EMA meeting of global regulators highlights importance of large-scale COVID-19 clinical trials
The third bi-weekly meeting held by the European Medicines Agency (EMA) under the umbrella of the International Coalition of Medicines … read more »
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 »
