In this article, published in the May edition of Pharmafocus, our Strategic Advisor, Dr Thomas Lönngren provides his perspective and early insights on the new UK Regulatory framework implemented by the MHRA.
The UK’s withdrawal from the EU was an historic event. In January 1973, the UK joined the European Economic Community and was rapidly involved in the development of further EU legislation, such as the 1975 Directives which established the first pan-European licensing.1 After being integrated in the European regulatory network for decades, benefiting from work-sharing, common legislation guideline procedures, and scientific standards, the UK will now perform all this on its own.
“This process does not happen in an instant,” Thomas Lönngren, Strategic Advisor at NDA Group comments. “It will take a long time to build a new fully flexible independent regulatory system, with all its complexity and resourcing issues. It is a huge task for the MHRA to undertake.”
An essential part of the new legislative framework that the UK government has put in place is to ensure that leaving the EU does not cause disruption to the supply of pharmaceuticals. And so far, it seems to have worked without any interruptions.
“From my perspective,” Lönngren continues, “the UK has put a very interesting new regulatory system in place. It is well balanced, maintaining basic regulatory principles and scientific guidelines coming from the EU, while implementing a new regulatory standard.”