The Brexit test: protecting pharmaceutical quality standards through better analysis

05 December 2019

Peter Morgan / European Pharmaceutical Review

In the wake of Brexit, the pharma industry will need to respond to a new regulatory landscape. Peter Morgan discusses how businesses have to prepare for the oncoming political changes, all whist retaining high pharmaceutical product quality.

As the end of 2019 approaches, the pharmaceutical industry is no closer to really understanding the impact of the UK’s planned departure from the EU than they were when the referendum was held in June 2016.
Almost nine months on from the original planned date of Brexit, the UK’s strategy for leaving the EU – and the consequences this will bring in terms of trans-European trade and product regulation – remains nebulous and definitive answers are unlikely to be forthcoming until after the general election on 12 December at the very earliest. However, for drugmakers in the UK, Europe and beyond, waiting this long to make preparations for all contingencies is not a viable option.
Should Brexit go ahead at the end of January 2020 as planned, this will inevitably bring about major changes to the way pharmaceuticals are tested, analysed and regulated within the UK and European markets. Given the pivotal importance of established quality assurance methodologies in the field of medicine, manufacturers need to be doing all they can to ensure their internal QC standards are robust enough to withstand any challenges Brexit may bring.


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