Of the 16 products containing a new active substance (NAS) approved by the UK regulator, the MHRA, in the first half of 2024, 15 were the subject of a reliance procedure that took account of existing EU decisions on marketing authorization. Seven of the products were orphan drugs for rare diseases. (See Table 1 below.)
In the same period, the European Commission issued centralized marketing authorizations for 20 NAS-containing