Pharma and biotech companies seeking entry into the US and EU markets may request advice from both agencies through the Food and Drug Administration (FDA) and European Medicines Agency (EMA) Parallel Scientific Advice (PSA) Program. However, few companies seem to be opting for the program, with only 22 drugs getting simultaneous review in the past five years.
According to , “Part of the problem is that both agencies have to agree to take up the joint review, and in that five-year window, FDA and EMA officials said that of the 11 denied reviews, four were not accepted because they were too early in development (i.e. not the subject of a pre-IND or IND), another four weren't accepted because the product included a device (although EMA now says that it can review device components moving forward), and the other three had more nuanced reasons for not being accepted.”
To read more, click here.
(Source: Endpoints News, March 9th, 2023)
