EU explains criteria for issuing duplicate marketing authorisations
This article was originally published in SRA
Pharmaceutical companies seeking duplicate/multiple marketing authorisations for drugs approved under the European centralised procedure can now refer to a new document issued by the European Commission that explains the criteria applied for granting such authorisations1,2.
You may also be interested in...
Companies are being encouraged to become “early adopters” of the EU Clinical Trials Information System when it goes live in December 2021.
Drug companies will be able to “play around” with the new EU Clinical Trials Information System in a secure testing environment before it goes live in approximately 15 months.
The Canadian authorities have put in place an expedited pathway for authorizing new COVID-19 drugs and vaccines that offers a more agile approach to reviewing data than what was previously allowed.