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.