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
In August 2022, the European Commission published a revision to Annex 1 “Manufacture of Sterile Medicinal Products” in EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines that will significantly impact...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 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
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 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
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 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
The UK Government has published guidance for life sciences companies on the Brexit implementation period, which is intended to take effect from 30 March 2019 to the end of 2020. ...more
The White Paper appears largely positive for the life sciences industry, incorporating many of the key asks from the industry across its priority areas of regulation, trade, people and innovation....more
On 19 June 2018, the European Medicines Agency (EMA) published updates to its Brexit Q&A document for human and veterinary medicines authorised via the centralised procedure and to its practical procedural guidance on making...more
6/29/2018
/ Animal Drugs ,
EU ,
European Medicines Agency (EMA) ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Standards ,
UK ,
UK Brexit
The UK Government has published a response to the recommendations set out in the Health and Social Care Committee’s Report dated 21 March 2018 on “Brexit: medicines, medical devices and substance of human origin”, which...more
The UK Government has published a response to the recommendations set out in the Health and Social Care Committee’s Report dated 21 March 2018 on “Brexit...more
The Business, Energy and Industrial Strategy Committee, a parliamentary select committee, has published a report on the consequences of Brexit on the UK pharmaceutical industry. ...more
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
The UK tax authority HM Revenue and Customs (HMRC) has published a series of practical guidance documents and additional online information to assist companies with understanding and complying with the new UK ‘Soft Drinks...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
An updated Model Clinical Trial Agreement (mCTA) has been published for industry-sponsored clinical trials involving patients in National Health Service (NHS) or Health and Social Care (HSC) hospitals in the UK....more
The UK government has published a White Paper setting out its new Industrial Strategy and, as part of that strategy, has agreed a Sector Deal with the UK life sciences sector. ...more
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 UK Food Standards Agency (FSA) is consulting on its proposals to amend the Feed Law Code of Practice and Practice Guidance. The Code and Guidance have to be taken into account by local authorities when enforcing feed law...more
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