A timely market introduction is a critical component of any drug development strategy – not only from a commercial stand point, where an early introduction can mean beating competition to market or simply significantly increased revenue, but also to patients awaiting better or alternative treatment options.
The debate around how regulators can facilitate this process on both sides of the Atlantic has resulted in new pathways for new medicines of major public interest. The FDA have the Breakthrough/RMAT pathways, and in the EU, EMA has put the PRIME process in place.
In this white paper, Steffen and Eva discuss the different tools available to European regulators and the experiences so far with the PRIME pathway.
To read the full article download the PDF
How we can help?
NDA Group supports life science companies all over the world with the aim to streamline the global development and commercialization process in order to accelerate patient access to important medical therapies.
Whatever regulatory hurdle you’re facing, we can help you optimize every regulatory interaction and shape the dialogue about your product to create a more direct path to approval.
To learn more about our services and how we can help click here
Or contact us at firstname.lastname@example.org to talk to one of our experts.
The post Prime – The European approach to expedited pathways appeared first on NDA Group.