What new guidance on anonymisation from the UK Information Commissioner’s Office (ICO) means for healthcare and life sciences companies....more
Pharmaceutical companies promoting prescription-only medicines to health professionals and other relevant decision makers in the UK must now adhere to revised industry standards that came into operation from 1 October 2024...more
The MHRA recently published an update on its plans for MedTech regulatory change. The update confirmed that the new framework will be introduced through four statutory instruments to update and replace the UK Medical Devices...more
Innovation fuels business growth and ushers in success, yet it brings its own set of challenges. In our latest issue, we explore innovative products and processes including:
- The EU’s new Unified Patent Court...more
6/17/2024
/ Artificial Intelligence ,
EU ,
Financial Regulatory Reform ,
Healthcare ,
Innovative Technology ,
Intellectual Property Protection ,
Life Sciences ,
Machine Learning ,
Regulatory Agenda ,
Regulatory Requirements ,
Technology Sector ,
Unified Patent Court
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 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
On Friday 21st October 2022, the Medicines and Healthcare Products Regulatory Agency (MHRA) wrote to the medical device industry to explain its intention:
- To extend the current standstill period by twelve months from...more
Today’s global healthcare marketplace is marked by unprecedented transformation. This presents both challenges and opportunity to today’s market participants. We know how important it is to structure cross-border investments...more
6/1/2022
/ Anti-Kickback Statute ,
Artificial Intelligence ,
Cross-Border ,
Global Market ,
Healthcare ,
Investment ,
Investors ,
Life Sciences ,
Medical Technology Companies ,
Merger Controls ,
Pharmaceutical Industry ,
Technology Sector ,
Telemedicine
On February 11, 2021 the UK Department of Health and Social Care published its White Paper setting out legislative proposals for a Health and Care Bill. The White Paper proposes wide changes to the structure of the NHS in...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 Legal Impact in Europe on Pharmaceutical and Medical Device Companies -
The current crisis mode has triggered legal and commercial issues that affect the pharmaceutical and medical device industry across...more
5/27/2020
/ Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
European Competition Network (ECN) ,
Exports ,
Force Majeure Clause ,
Homeland Security Cybersecurity & Infrastructure Security Agency (CISA) ,
Imports ,
Intellectual Property Protection ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Remote Working ,
UK ,
Wine & Alcohol
The UK government has introduced sweeping changes to the UK health legislation as it urgently prepares for the impact of the Coronavirus (COVID-19) pandemic, including increased admissions and demand for intensive care...more
4/1/2020
/ Affiliated-Business Arrangements ,
Business Interruption ,
Coronavirus/COVID-19 ,
Financial Stimulus ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Medical Devices ,
Medical Supplies ,
Relief Measures ,
Small Business ,
Tax Relief
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
In the burgeoning global fertility services sector, sophisticated investors may see opportunities to consolidate and deliver greater success by providing financial discipline as well as professional managerial support. ...more
5/22/2019
/ Acquisitions ,
Fertility Treatments ,
Global Market ,
Health Care Providers ,
Investment ,
Investors ,
Life Sciences ,
Mergers ,
Pregnancy ,
Private Equity ,
Private Equity Firms ,
Sperm Donors