The EU regulation designed to facilitate secondary use of clinical data for research brings benefits for health research, but also poses challenges for companies....more
4/18/2025
/ Clinical Trials ,
Data Controller ,
Data Protection ,
Data-Sharing ,
EU ,
General Data Protection Regulation (GDPR) ,
Healthcare ,
Intellectual Property Protection ,
International Data Transfers ,
Medical Research ,
Member State ,
New Legislation ,
Opt-Outs ,
Personal Data ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Scientific Research
Welcome to the latest edition of our Healthcare & Life Sciences Market Update, in which we explore the evolving landscape of investment trends, regulatory challenges, and strategic opportunities shaping the global market....more
On 3 May 2022, the European Commission launched its proposal for a Regulation for the European Health Data Space to “unleash the full potential of health data”. However, questions arise as to whether this proposal is a...more
11/2/2022
/ Biometric Information ,
Consent ,
Data Controller ,
Data Protection ,
Electronic Protected Health Information (ePHI) ,
EU ,
European Data Protection Board (EDPB) ,
General Data Protection Regulation (GDPR) ,
Health Care Providers ,
Medical Research ,
Personal Data ,
PHI ,
Portability ,
Public Health ,
Public Policy ,
Transparency
The response includes a considered implementation plan to strengthen the regulation of medical devices and in vitro diagnostics, improve patient safety, and foster innovation post-Brexit.
On 26 June 2022, the UK Medicines...more
7/1/2022
/ Consultation ,
Diagnostic Tests ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Pharmaceutical Industry ,
Proposed Regulation ,
Public Comment ,
Public Health ,
Technology ,
UK ,
UK Brexit
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
2/10/2022
/ Clinical Trials ,
Digital Health ,
EU ,
EU Clinical Trials Regulation (CTR) ,
Health Care Providers ,
Joint Venture ,
Life Sciences ,
Mergers ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Standards ,
UK ,
Venture Capital
The agency’s consultation on the post-Brexit regulatory framework for medical devices and diagnostics aims to support innovation and sustainability, among other goals.
A 10-week consultation launched by the UK’s Medicines...more
The agreement provides guidance across several areas for the life sciences sector, though gaps remain.
The widely anticipated EU-UK Trade and Cooperation Agreement (the Agreement) came into effect on 1 January 2021 after...more
3/4/2021
/ Clinical Trials ,
Data Privacy ,
EU ,
Life Sciences ,
Manufacturers ,
Marketing Authorization Application ,
Medical Devices ,
Pharmaceutical Industry ,
Trade Agreements ,
UK ,
UK Brexit
The MHRA offers new guidance on how medical devices will be regulated in the UK from 1 January 2021.
On 1 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on how medical...more
UK companies interested in producing ventilators and other critical equipment may benefit from regulatory exemptions and use government product specifications.
On 16 March 2020, Prime Minister Boris Johnson called on the...more
European Commission proposes one-year postponement in light of the COVID-19 crisis.
On 25 March 2020, the European Commission announced that it was working on a proposal to postpone the date of application for the new EU...more
Recent legal and regulatory developments pave the way for an increased commercialisation opportunity in cannabis-based medicines, but complex rules require careful navigation.
The National Institute for Health and Care...more
Companies should act now to prepare for the full implementation of the MDR and IVDR.
On 26 May 2020, Regulation (EU) 2017/745 on medical devices (MDR) will become fully active, reflecting an overhaul of the current...more
The guidance provides helpful clarity on key regulatory changes impacting life sciences companies in the event of a no-deal Brexit.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a...more
4/4/2019
/ Article 50 Treaty of the EU ,
EU ,
European Economic Area (EEA) ,
Health Care Providers ,
Healthcare ,
Life Sciences ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
New Guidance ,
New Legislation ,
No-Deal Brexit ,
Pharmaceutical Industry ,
Time Extensions ,
UK ,
UK Brexit ,
Withdrawal Agreement