MHRA LAUNCHES UK CLINICAL TRIAL REGULATION CONSULTATION -
The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom),...more
4/29/2022
/ Clinical Trials ,
Data Privacy ,
Data Security ,
Data Transfers ,
Draft Guidance ,
EU ,
General Data Protection Regulation (GDPR) ,
Life Sciences ,
Medical Devices ,
Medical Research ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Privacy Laws ,
Regulatory Agenda ,
Research and Development ,
UK
The combination of the Coronavirus (COVID-19) pandemic and the imminent end of the Brexit transition period means a fast-changing regulatory environment for medicines.
On 16 October 2020, the UK Government made changes to...more
10/28/2020
/ Applications ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Exports ,
Imports ,
Licenses ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
New Regulations ,
UK ,
UK Brexit
The impact of Coronavirus (COVID-19) on pharmaceutical and medical device companies has been unique as, not only have these businesses had to set up emergency management systems practically overnight in order to maintain...more
4/2/2020
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
Export Bans ,
Medical Devices ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
State of Emergency ,
Supply Chain ,
UK ,
UK Brexit
The United Kingdom is no longer a member of the European Union and has entered into a transition period until December 31 2020, unless an extension of 1 or 2 years is agreed by July 1 2020 (the Brexit Long Stop...more
The MDR and other recent developments in the health care regulatory landscape pose new opportunities and challenges for medical software companies and investors in digital health in the United Kingdom. Although the regulatory...more
7/3/2019
/ Biotechnology ,
Certification Requirements ,
Code of Conduct ,
Digital Health ,
EU ,
Innovation ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Member State ,
New Regulations ,
No-Deal Brexit ,
Regulatory Oversight ,
UK
Data Inspections in China: Increased Supervision and Compliance -
Data protection inspections have become more frequent for companies with operations in China. Many companies are struggling for guidance on how to...more