May 12th, 2014, 16.00-17.00 CET (15:00 UK, 10:00 EST)
The EMA’s announcement of a pilot project in adaptive pathways, the UK government’s Early Access to Medicines Scheme (EAMS) and the FDA’s highly-publicised Breakthrough programme demonstrate an increase in international competition for a better, faster, approval plan for the development of needed new medicines.
For more information:
Comparison of EU and USA licensing flexibilities (click to download the full table)
Comparison of Breakthrough therapy designation and MHRA processes (click to download to download the full table)
Read the full report from MHRA: Report of the Expert Group on innovation in the regulation of healthcare – 25 September 2013