Adjusting the route to market is vital to support innovation and timely approvals for products that could cover unmet or high medical needs. However, what remains unclear is how to shape regulatory strategy to overcome the barriers and whether the evidence gathered for authorisation marries up with health technology assessment (HTA) strategy. Bottlenecks in bringing products onto the market and legislative frameworks at national level are of particular interest.
An interactive workshop held jointly by TOPRA and the DIA in June 2015 provided a forum to identify the challenges of adaptive pathways, including additional evidence generation and the barriers in global registration programmes. A Reflection Paper generated by this workshop highlights the themes identified, a summary of the discussions, and recommendations and key points is available below.