UK biotech sector welcomes extension of EU regulatory reliance

The UK’s BioIndustry Association (BIA), the trade body for innovative life sciences, has welcomed a one-year extension to the European Commission Decision Reliance Procedure (ECDRP).

Introduced in January 2021 after the UK left the European Union, the country’s newly-independent medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has now extended the approval pathway until the end of 2023.

The regulatory route permits biotech firms to apply for UK marketing authorization for products which have already been granted EU marketing authorization, via the European centralized procedure.