On September 1, 2020, the UK’s medicines and medical devices regulator released the MHRA post-transition information, an extensive suite of guidance on the UK regulatory regime post the Transition Period expiring on December 31, 2020. The new guidance spreads out across dozens of documents covering the following topics: Clinical trialsDevicesLicensingImporting…

Whilst we wait for the outcome of the UK general election, we thought it would be interesting to provide an update on the latest developments regarding Brexit and its possible implications on the regulatory framework for the approval of medicines in the EU. Following the latest extension to January 31,…

In a letter dated November 6, 2019, Steve Oldfield, Chief Commercial Officer at the Department of Health and Social Care (DHSC), expresses gratitude to the industry for the high levels of preparation ahead of the October 31, 2019, Brexit deadline. However, he states that the multi-layered approach put in place…

31 October is fast approaching and while a hard Brexit scenario may have become less likely, governments in the EU-27 have been ramping up preparations in case the UK would leave the EU by the end of the month (or any later date) without a deal. Industry has done its…