The United Kingdom medical devices regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has announced that the upcoming changes to UK medical device legislation will be pushed back from 1 July 2023 to 1...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its response to its consultation on the future regulation of medical devices in the United Kingdom which ran between September and November...more
The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published a raft of guidance on how various aspects of the UK regulatory regime for medicines will operate in England, Wales and Scotland (together Great...more
The National Institute for Health and Care Excellence ("NICE") has published a revised timetable for reviewing its methods and processes for health technology assessments ("Methods Review"). ...more
The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published new guidance (the "Guidance") on how medical devices will be regulated in Great Britain ("GB") (England, Wales and Scotland) and in Northern...more
9/25/2020
/ Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Member State ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements ,
UK ,
UK Brexit
As of 23 June, the UK government can scrutinize certain foreign takeovers and other acquisitions to ensure that they do not jeopardize the UK's capability to combat, and mitigate the effects of, a public health emergency...more
6/25/2020
/ Coronavirus/COVID-19 ,
Critical Infrastructure Sectors ,
Cross-Border Transactions ,
Foreign Acquisitions ,
Foreign Direct Investment ,
Foreign Investment ,
Health and Safety ,
Healthcare Facilities ,
Public Health ,
Restricted Transactions ,
Takeovers ,
UK
The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time.
...more
3/25/2020
/ Adverse Events ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
EU ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Regulatory Oversight ,
REMS
The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more
3/17/2020
/ Biopharmaceutical ,
Biotechnology ,
Centers for Disease Control and Prevention (CDC) ,
China ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Crisis Management ,
Emergency Management Plans ,
Food and Drug Administration (FDA) ,
Good Clinical Practices ,
Infectious Diseases ,
Institutional Review Board (IRB) ,
Italy ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Netherlands ,
Public Health ,
Reimbursements ,
Research and Development ,
Supply Chain ,
Travel Restrictions ,
Trump Administration ,
UK ,
Vaccinations ,
Vendors ,
World Health Organization
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance on the management of clinical trials in the context of coronavirus....more
At the end of last week, the World Health Organisation (WHO) upgraded the global risk assessment of the novel coronavirus to "very high." This comes shortly after the United Kingdom saw its first fatality as a result of...more
3/3/2020
/ Business Interruption ,
Coronavirus/COVID-19 ,
Health and Safety ,
Infectious Diseases ,
Medical Devices ,
Pharmaceutical Distribution ,
Pharmaceutical Industry ,
Popular ,
Public Health ,
Risk Assessment ,
Suppliers ,
Supply Chain ,
UK
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
2/26/2020
/ 3D Printing ,
AIDS ,
Analytics ,
Artificial Intelligence ,
Biosimilars ,
Biotechnology ,
Blockchain ,
California Consumer Privacy Act (CCPA) ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Defense (DOD) ,
Digital Health ,
Drug Distribution ,
Drug Pricing ,
EU ,
Federal Funding ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Technology ,
HIV ,
Incident Response Plans ,
Intellectual Property Protection ,
Life Sciences ,
Medical Device Data System ,
Medical Devices ,
Medical Software ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Procurement Guidelines ,
Regulatory Standards ,
Research and Development ,
Right to Try ,
Robotics ,
Supply Chain ,
Telehealth
Digital health offers huge potential for improving care and alleviating the increasing burden on our over-stretched healthcare systems. However, its uptake remains slow and varies significantly across the EU....more
11/25/2019
/ 21st Century Cures Act ,
Data Management ,
Data Security ,
Digital Health ,
EU ,
Health Care Providers ,
Health Information Technologies ,
Information Technology ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry
Following the recent agreement to delay Brexit until 31 January 2020, the UK Department of Health and Social Care ("DHSC") has written to suppliers of UK medicines and medical devices to confirm the continued contingency...more
11/8/2019
/ Border Security ,
Contingency Plans ,
Cross-Border Transactions ,
Customs ,
EU ,
Imports ,
Medical Devices ,
Member State ,
No-Deal Brexit ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Procurement Policies ,
Regulatory Requirements ,
Strategic Planning ,
Supply Chain ,
UK Brexit ,
Withdrawal Agreement
The Queen's Speech, which set out the government's proposed plan for new legislation, included a new "Medicines and Medical Devices Bill". The government's background briefing describes the purpose of the Bill as ensuring...more
The policy behind SDIL is to reduce childhood obesity by encouraging producers to change the recipes and lower the sugar content of the drinks. The Government estimates that over 50% of manufacturers had done so before SDIL...more
8/27/2019
/ Beverage Manufacturers ,
Business Model ,
Multinationals ,
Obesity ,
Plant Based Products ,
Public Health ,
R&D ,
Regulatory Standards ,
Retail Market ,
Retailers ,
Soda Tax ,
Tax Rates ,
Transfer Pricing ,
UK
On May 16 the second edition of our new global series, Life Sciences and Health Care Horizons, took place in London featuring two panel discussions that focused on the challenges and opportunities in two of the sector’s...more
6/14/2019
/ Agribusiness ,
Artificial Intelligence ,
Cannabis Products ,
Data Collection ,
Data Protection ,
Decriminalization of Marijuana ,
Hemp ,
Intellectual Property Protection ,
Life Sciences ,
Marijuana ,
Marijuana Related Businesses ,
Marketing Perspectives ,
Patents ,
Personal Data ,
Pharmaceutical Industry ,
Popular ,
R&D ,
Regulatory Standards ,
Supply Chain ,
UK
With the possibility of the UK leaving the EU on 29 March 2019 (a "no deal" Brexit) still on the table, life sciences companies are continuing their "no deal" preparations....more
3/21/2019
/ EU ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Member State ,
No-Deal Brexit ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Standards ,
UK ,
UK Brexit
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
3/18/2019
/ Artificial Intelligence ,
Asia ,
Biologics ,
Biotechnology ,
Data Breach ,
Digital Health ,
Information Technology ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Chain
Do you have a centralised EU marketing authorisation holder, orphan designation holder, manufacturing activities including import, batch control or batch release sites, a Qualified Person for Pharmacovigilance (QPPV),...more
Do you hold a CE certificate of conformity issued by a UK notified body? Are your manufacturing activities, authorised representative, suppliers, customers or contracting parties located in the UK?
...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance on how the UK would regulate medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019...more
1/7/2019
/ Clinical Trials ,
EU ,
Generic Drugs ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Member State ,
No-Deal Brexit ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Standards ,
UK ,
UK Brexit
The UK Department of Health and Social Care (DHSC) has published a new policy paper “The future of healthcare: our vision for digital...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related clinical trials that would need to be...more
10/5/2018
/ Consultation ,
EU ,
European Medicines Agency (EMA) ,
Imports ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Member State ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agencies ,
Regulatory Oversight ,
UK ,
UK Brexit
On 23 August 2018, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the network of the National Competent Authorities in the European Economic Area (EEA), published the work programme of their...more
9/6/2018
/ Biotechnology ,
EU ,
European Economic Area (EEA) ,
European Medicines Agency (EMA) ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Standards ,
Supply Chain ,
UK ,
UK Brexit ,
Veterinary Products
The UK government has published several guidance documents on how to prepare for Brexit in the event of a "no deal" scenario (i.e. if the UK and EU do not agree a future trade deal and the proposed post-Brexit...more