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 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
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
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
European regulators are expected to align their processes and guidance to accommodate the EDPB’s recommended approach to processing special categories of personal data.
In January, the European Data Protection Board (EDPB)...more