How Brexit Affects Clinical Research


Clearly, the UK exiting from the EU will have a profound impact on the industry.  Many of the agreements bargained for as part of the EU will need to be renegotiated.  I do not necessarily see this as a negative; perhaps time consuming, but not negative.

For one, it will give companies the opportunity to negotiate better deals.  From a regulatory standpoint, it will now require separate submission of studies, again time consuming but not necessarily a negative.  Since the UK had a strong position towards the development of EMA’s operation and review process, I would not foresee too much deviance from those established practices as the UK re-establishes its own regulatory body.

There is a clear global effort to harmonize and standardize regulatory requirements and the submission process.  Change can be good!

Please share your thoughts on this important development in global clinical research.

About JeanMarie Markham

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