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To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....more
The European Banking Authority has published its final amendments to the Regulatory Technical Standards on the market risk framework, also known as the Fundamental Review of the Trading Book. The EU Capital Requirements...more
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
On 30 June 2022, the European Council (Council) and the European Parliament (Parliament), announced that they had reached a provisional agreement on the proposal for regulation on markets in cryptoassets (MiCA), which covers...more
With this series we provide insights on what you need to know now about the new EU Clinical Trials Regulation (“CT Regulation”). Episode : Protection of vulnerable groups This part of the series is about the protection of 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
The latest Consultations launched by the European Banking Authority (EBA) and the Bank of Italy on regulatory capital requirements for banks may lead to opportunities for alternative lenders, as traditional financiers may...more
On 14 April 2021, the EU Commission’s long-awaited draft proposals for the regulation of artificial intelligence (AI) were leaked. The proposals, which are due to be formally announced on 21 April, set out a bold and...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
A new draft EU Regulation aims to encourage the sharing and re-use of data and foster a data-driven economy that shares the benefits of Big Data whilst respecting individuals’ rights in personal data and commercial rights in...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
The European Commission announced recently that it seeks feedback on proposals to adopt new regulations which establish the framework for achieving EU-wide 'climate neutrality' by reducing greenhouse gas emissions to net zero...more
Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....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
LEGISLATION, REGULATIONS & STANDARDS - FDA Issues Warning Letters, Consumer Update On CBD, Sparking Litigation Against CBD Cos. - The U.S. Food and Drug Administration (FDA) has issued a consumer update on cannabidiol...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
LEGISLATION, REGULATIONS & STANDARDS - USDA Receives Hundreds Of Comments On Hemp Interim Rule - Two weeks after opening a comment period on an interim final rule on hemp farming, the U.S. Department of Agriculture...more
Whilst political uncertainty may have businesses’ attention fixed, the Hogan Lovells Global Survey on Digital Regulation: ‘A Turning Point for Tech’ suggests that tech companies should be looking elsewhere. During yesterday’s...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
There is a growing trend to regulate biometric data and severely punish companies that do not adequately protect this data. Every company that collects or uses biometric data should be careful to ensure compliance with...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