If the UK government changes the rules for clinical trials after Brexit, the regimes in the UK and the EU will diverge and possibly make trials more complex and costly, as Rachel Bradley of Penningtons Manches reports.
A new regime for clinical trials in Europe is coming into force in 2018. However, there are uncertainties about what clinical trials legislation will apply in the UK once it leaves the EU. This article is a brief summary of the changes that will come into force for businesses based in Europe and for global businesses running clinical trials in Europe, and the potential impact of Brexit.
Currently, clinical trials on medicinal products for human use conducted in EU member states are governed by the EU’s clinical trials directive (Directive 2001/20/EC), together with national legislation to implement the directive. As a result, its interpretation and application is not uniform across member states. The directive has faced criticism for its bureaucracy and complexity, with multiple applications and authorisations required where a trial is conducted in multiple member states.
When it comes into force as expected in 2019, the EU clinical trials regulation (No. 536/2014) is set to overhaul the regulatory regime for clinical trials in Europe. The regulation aims to harmonise the application and authorisation processes throughout the EU and to provide greater transparency on clinical trials and their results. It is hoped this will be achieved through a new, publicly accessible clinical trials database to be set up and administered by the European Medicines Agency (EMA), in collaboration with the member states and the European Commission.
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Rachel Bradley, Brexit, Penningtons Manches, UK government, clinical trials, EMA, UK industry, clinical trial data, medicinal products, Manches