News about GMP/cGMP


MHRA: No Sudden Changes to Regulatory Framework

The MHRA (Medicines and Healthcare products Regulatory Agency, UK) has published an update on the negotiations between the EU and the UK which have now entered the second phase.

In December 2017 guidelines for this phase were adopted which mainly contain transition plans and the framework for the future relationship. A joint report was also issued to make clear that “goods placed on the market under Union law before the withdrawal date may freely circulate on the markets of the UK and the Union with no need for product modifications or re-labelling; be put into service where provided in Union law, and that the goods concerned should be subject to continued oversight.

The EU guidelines acknowledge the proposal put forward by the UK for a time-limited implementation period, based on the existing structure of EU rules and regulations. The aim is for access to one another’s markets to continue on current terms throughout this period, and for it to be based on the existing structure of EU rules and regulations. The MHRA ensures industry associations and other stakeholders that there would be no sudden changes to the UK regulatory framework and that a pragmatic approach would be established, in case of negotiation problems. The BIA (BioIndustry Association), as well as the ABPI - the trade group representing the pharmaceutical industry in the UK - has responded to the MHRA's statement reiterating the importance of getting Brexit right:

"For patients and the public there are very real consequences of failing to get this right, and we will continue to work with our members, regulators, governments and the Commission to mitigate these risks. The complex issues surrounding medicines regulation and supply chain need to be front and centre in the second phase of talks."


MHRA: Update on negotiations

ABPI: Statement

BIA: Statement