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On 12 October 2023, the Medicines and Healthcare products Regulatory Agency (the MHRA) announced that the healthcare and life sciences sector will benefit from a new streamlined notification scheme for lowest-risk clinical...more
The Prudential Regulation Authority (“PRA”) has published Consultation Paper 15/23 – Securitisation: General requirements (“CP 15/23”) setting out its proposed rules to replace retained EU law requirements on...more
The UK Draft Media Bill, which is set to reshape the broadcasting landscape in the UK, is now in the pre-legislative scrutiny phase. In this Part 3 of our series on the Draft Media Bill, we set out the next steps before the...more
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
Welcome to the first edition of our European Healthcare & Life Sciences Market Update, a new report summarising key emerging trends, opportunities, and challenges facing the market in 2022. During the last 12 months, the...more
Systemically important payment systems: ECB Regulation and Decisions - European Central Bank (ECB) Regulation (EU) 2021/728, which amends the Regulation on oversight requirements for systemically important payment systems...more
EU consumer credit websites: European Commission findings from mini-sweep - The European Commission has published an updated webpage providing information on its findings during a mini-sweep of consumer credit websites in...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 government published a Green Paper on December 15 that includes proposals to shape the future of public procurement in the United Kingdom by speeding up and simplifying public sector procurement processes....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
In a July 2020 speech on climate action in the financial industry, Sarah Breeden, executive director for UK Deposit Takers Supervision, said the industry is “at the start of a critical decade for climate action where the...more
On Friday 16 July 2020, the UK communications regulator, Ofcom, published a consultation on video-sharing platform regulation, calling for views by 24 September 2020. ...more
With the recent news that the Association of British Insurers (ABI) has called for new rules to reflect the increased use of AI and machine learning in the insurance industry, comes a reminder that there is still a...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
The fair treatment of vulnerable customers is a key priority for the FCA. It is an important topic not least because the FCA considers that half of UK adults (25.6 million people) display one or more characteristics of...more
LEGISLATION, REGULATIONS & STANDARDS - Bipartisan Bill Introduced to Standardize Food Date Labels - U.S. Reps. Chellie Pingree (D-Maine) and Dan Newhouse (R-Wash.) have introduced the Food Date Labeling Act, which aims...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
The Taskforce’s final report outlines the UK’s policy and regulatory approach to crypto-assets and distributed ledger technology in financial services. Key Points: ..The Report provides an overview of crypto-assets and...more
EPA Releases TSCA Assessment Documents For Flame Retardant Chemicals: On August 18, 2014, the U.S. Environmental Protection Agency (EPA) released for public comment three Problem Formulation and Initial Assessment documents...more