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The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom), recently announced a consultation to change the UK clinical trial...more
Brexit finally became a reality on 31 December 2020, as the UK reached the end of the agreed Transition Period after the UK’s departure from the EU. The UK government has heralded Brexit as a “historic opportunity to...more
The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published a raft of guidance on how various aspects of the UK regulatory regime for medicines will operate in England, Wales and Scotland (together Great...more
The UK government has indicated that the UK’s approach to public procurement will fundamentally change post-Brexit. While it remains to be seen whether such a fundamental change will be possible in practice, the UK...more
Irrespective of whether the UK leaves the EU with a withdrawal agreement, interest grows in the future of regulatory policy, the inter-connectivity of international financial services, and how firms from other countries will...more
At the Economic Club of New York, in keynote remarks, Chair Clayton reviewed the Securities and Exchange Commission’s recent initiatives. He highlighted the Commission’s adoption of Regulation Best Interest (Reg BI). ...more
Do you work in the automotive & mobility industry in the UK? Do you manufacture or sell vehicles, or parts of vehicles, in the UK? Are your manufacturing activities, suppliers, customers or contracting parties located in the...more
With the possibility of the UK leaving the EU on 29 March 2019 (a "no deal" Brexit) still on the table, life sciences companies are continuing their "no deal" preparations....more
Do you have a centralised EU marketing authorisation holder, orphan designation holder, manufacturing activities including import, batch control or batch release sites, a Qualified Person for Pharmacovigilance (QPPV),...more
As we approach the end of the post-crisis regulatory reform agenda, we are still witnessing fast-paced regulatory developments that are undeniably and significantly driven by Brexit — with no signs of things slowing down in...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance on how the UK would regulate medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019...more
Qualifying undertakings can comply with their obligations under the Regulations by having a certified Energy Management System. Post Brexit, certification will still be permitted by bodies accredited by the United Kingdom...more