European Union - October 14 2019
The European Medicines Agency (EMA) issued a qualification opinion following a request concerning proprietary eSource DDC (Direct Data Capture)...
Grégoire Paquet.
United Kingdom, European Union - October 1 2019
On 18 September 2019, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance regarding the role and...
Grégoire Paquet.
USA - September 18 2019
A newly-published study has compared more than a hundred new drug marketing applications at both the European Medicines Agency (EMA) and the Food and...
Grégoire Paquet.
European Union - September 6 2019
On 21 August 2019, the European Medicines Agency (EMA) published questions and answers regarding imported advanced therapy medicinal products (ATMP)...
Grégoire Paquet.
Luxembourg, Poland, Austria, Spain, United Kingdom, Belgium, European Union, France, Germany, Greece, Ireland, Italy - September 4 2019
With the anticipated departure of the United Kingdom from the EU, medical device manufacturers are exploring whether it will be possible to continue...
Alexander Wenzel, Grégoire Paquet.
