The UK Medicines and Healthcare products Regulatory Agency (MHRA's) has published a Statement of policy intent: international recognition of medical devices outlining its proposal for the International Recognition Procedure...more
On 30 April 2024, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) published its strategic approach to AI and the steps it is taking to implement the UK Government's AI White Paper, published in August 2023....more
The UK CMA has published practical guidance confirming its commitment to ensuring that competition law does not hinder collaborations between medicine manufacturers which aim to make innovative and life-saving combination...more
The UK Government has recently made available a draft of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023 (2023 Regs). Although these are far from being in force yet,...more
Today marks the commencement of the legislation that extends the standstill period for EU CE-marked medical devices to continue to be placed on the market in Great Britain (England, Wales and Scotland)....more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the introduction of new international recognitions routes for the approval of medicines that are already authorised in Australia, Canada, the...more
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an update on the timing of the reform of the current UK legislation, the Medical Device Regulations 2002 (UK MDR), and the transitional arrangements...more
We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Boston for the first time since the pandemic. At the event, Hogan Lovells attorneys Eliza Andonova, Ina Brock, Kristin...more
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 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
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
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