The UK Government has confirmed that it is committed to implementing the new EU Clinical Trials Regulation (EU) 534/2014 (“EU CTR”) into UK law post-Brexit. ...more
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
4/4/2018
/ 3D Printing ,
Acquisitions ,
Artificial Intelligence ,
Biologics ,
Biosimilars ,
Biotechnology ,
Blockchain ,
Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Digital Health ,
Distributed Ledger Technology (DLT) ,
Drug Pricing ,
Emerging Markets ,
EU ,
General Data Protection Regulation (GDPR) ,
Generic Drugs ,
Innovation ,
Life Sciences ,
Medical Reimbursement ,
Mergers ,
Over The Counter Derivatives (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Private Equity ,
Regulatory Oversight ,
Supply Chain ,
Transfer Pricing ,
UK Brexit ,
Yates Memorandum
The UK House of Commons Health and Social Care Committee has published the findings of its six-month long investigation into the impact of Brexit on medicines, medical devices and substances of human origin. ...more
3/28/2018
/ Biosimilars ,
Biotechnology ,
EU ,
European Medicines Agency (EMA) ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Member State ,
Pharmaceutical Industry ,
Referendums ,
Regulatory Oversight ,
UK ,
UK Brexit
On the same day as the European Council voted to move the European Medicines Agency (EMA) from London to Amsterdam, the UK Parliament issued a briefing paper on Brexit and medicines regulation. ...more
11/22/2017
/ EU ,
European Medicines Agency (EMA) ,
Imports ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Member State ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Referendums ,
Regulatory Agencies ,
Regulatory Oversight ,
UK ,
UK Brexit
The European Commission has published a draft implementing Regulation setting out the proposed official EU list of authorised novel foods.
A ‘novel food’ is a food or ingredient that has not been consumed to a significant...more
10/17/2017
/ Agricultural Sector ,
EU ,
European Commission ,
European Food Safety Authority (EFSA) ,
Food & Drug Regulations ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Novelty ,
Prior Authorization ,
Regulatory Oversight
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published an interactive guide to assist companies with understanding the requirements of the new EU Medical Device Regulation (“MDR”) and In Vitro...more
With the negotiations for the UK’s withdrawal from the EU formally under way, the UK healthcare sector is calling on the UK Government to make patient safety and access to medicines a priority in negotiations – and it appears...more
Life sciences companies in both the EU and the UK are beginning to speculate on what Brexit will mean for business. In this video, Elisabethann Wright, partner, and Jane Summerfield, counsel, in our European Life Sciences...more