The European Medicine Agency (EMA) is launching a priority scheme for therapies addressing unmet medical needs, similar to the FDA’s fast track.
The key objective is to help European patients get earlier access to therapies that could be lifesaving, and this could have significant impact on the European Biotech industry.
This new PRIME fast-track will include a number of perks for therapies that qualify as ‘priority medicines‘. These include a closer working relationship with the regulatory group, guidance through the process of designing and conducting clinical trials, and possibly a ‘nudge’ in the marketing authorization.
One of the primary targets of EMA are actually small and medium-size companies or academic spin-offs (so a lot of Biotechs), that have less regulatory experience – and benefit the most from the type of support that PRIME provides.
With this program, the EMA is more closely mirroring its American counterpart the FDA, which had already introduced an equivalent designation,