UK Reveals Plans For ‘Dynamic’ Post-Brexit Regulatory System

▤ Summary

While it plans to retain the existing EU rules that have been transposed into domestic legislation, it also wants the freedom to tailor its regulations in areas like clinical trials, advanced therapies and product labeling. The loss of this power, the government says, would “prevent the maintenance of a dynamic, fit for the future regulatory system capable of adjusting for future innovation, with expected negative impacts on patient outcomes, population health and the UK’s competitiveness in the food and life sciences sectors.” The bill would restore this power so that the government can easily make changes to the regulations as needed. This, it says, would allow the UK to keep up with “developments and innovations” and “cement our ability to enable early access to cutting edge technologies and break new ground in complex clinical trials.” Changes could include, for example, amending the requirements for new drug marketing, manufacturing and wholesaling authorizations, the import of active pharmaceutical ingredients, and the labeling and packaging of human medicines. This is necessary as we cannot foresee what medicines will be available in the future, nor whether information requirements might change for existing treatments if side-effects arise.” Finally, online pharmacies would be subject to a national registration scheme. The UK would require sellers to register with the MHRA and display a common logo on their websites; it could also decide to have additional safeguards or conditions as part of the scheme.

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