The Medicines and Healthcare products Regulatory Agency (MHRA) recently published long-awaited guidance confirming that there will be a delay in the implementation of new legislation for the Great Britain market and an...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
Today’s global healthcare marketplace is marked by unprecedented transformation. The seismic shifts in healthcare delivery and drug development during COVID-19 have, in 2021, continued to demonstrate the power and capacity...more
9/20/2021
/ Austria ,
Cannabis Products ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Data Protection ,
Denmark ,
Digital Health ,
EU ,
France ,
Germany ,
Healthcare ,
Information Technology ,
Investment ,
Italy ,
Medical Devices ,
Netherlands ,
Pharmaceutical Industry ,
Poland ,
Procurement Guidelines ,
Proposed Legislation ,
Spain ,
Supply Chain ,
Switzerland ,
Telemedicine ,
UK ,
UK Brexit ,
Whistleblowers
The UK Government has proposed changes to the procurement regime for public sector contracts in the UK. The proposals mark a radical divergence from the European procurement regimes post Brexit. The proposals are set out in a...more
The combination of the Coronavirus (COVID-19) pandemic and the imminent end of the Brexit transition period means a fast-changing regulatory environment for medicines.
On 16 October 2020, the UK Government made changes to...more
10/28/2020
/ Applications ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Exports ,
Imports ,
Licenses ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
New Regulations ,
UK ,
UK Brexit
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on the new rules that will govern the regulation of medical devices and in vitro diagnostic medical devices placed on the market in...more
The impact of Coronavirus (COVID-19) on pharmaceutical and medical device companies has been unique as, not only have these businesses had to set up emergency management systems practically overnight in order to maintain...more
4/2/2020
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
Export Bans ,
Medical Devices ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
State of Emergency ,
Supply Chain ,
UK ,
UK Brexit
The United Kingdom is no longer a member of the European Union and has entered into a transition period until December 31 2020, unless an extension of 1 or 2 years is agreed by July 1 2020 (the Brexit Long Stop...more
SPECIAL REPORT -
BREXIT: CHALLENGES AND OPPORTUNITIES -
In this report, we explain some of the key legal implications associated with the United Kingdom leaving the European Union (EU) without a deal for future...more
3/25/2019
/ Article 50 Treaty of the EU ,
Banking Sector ,
Court of Justice of the European Union (CJEU) ,
Data Protection ,
EU ,
European Securities and Markets Authority (ESMA) ,
Financial Institutions ,
General Data Protection Regulation (GDPR) ,
Hague Agreement ,
International Data Transfers ,
International Labor Laws ,
International Tax Issues ,
Pharmaceutical Industry ,
Supply Chain ,
UK ,
UK Brexit ,
Value-Added Tax (VAT) ,
Withdrawal Agreement ,
WTO
Data Inspections in China: Increased Supervision and Compliance -
Data protection inspections have become more frequent for companies with operations in China. Many companies are struggling for guidance on how to...more
Cross Border M&A: The Impact of Brexit, the Trump Administration, and China’s Crackdown on Capital Flight
The combination of Brexit, the Trump Administration, and China’s tightening grasp on capital, appear to have created...more
12/6/2017
/ Acquisitions ,
Bilateral Investment Treaties ,
Capital Markets ,
China ,
Cross-Border Transactions ,
Department of Justice (DOJ) ,
Dispute Resolution ,
EU Data Protection Laws ,
Federal Trade Commission (FTC) ,
Foreign Acquisitions ,
Foreign Investment ,
Health Care Providers ,
Insolvency ,
Mergers ,
NAFTA ,
Trump Administration ,
UK Brexit ,
UK Insolvency Act
For investors considering the UK care sector, the Care Quality Commission (CQC) State of Care report released 10 October 2017 again raises alarm bells. Beds in nursing homes declined meaningfully, and funding pressures are...more