Category: Regulation & compliance
COVID-19: Weekly Life Sciences Digest – Testing Kits for COVID-19
Natasha Leskovsek, Andrew Barr, Sarah-Jane Dobson, Edward Turtle, Harriet Jones and Julia Maskell
With COVID-19 heralding unprecedented changes in the sector, our life sciences products experts provide a weekly summary of key international developments to keep you up to date.
UK-specific guidance for the application and management of clinical trials in the context of COVID-19
Sarah-Jane Dobson and Amal Ali
The UK’s MHRA has stated it will be particularly flexible and pragmatic in authorising clinical trials connected to COVID-19, referring to its previous track record of having acted swiftly in past public health crises
2020 Vision – Looking Beyond COVID-19: Longer-Term Considerations for Supply and Manufacture of Products During COVID-19
Sarah-Jane Dobson, Andrew Barr and Richard Hopley
With COVID-19 causing a pivot or volume increase in production, companies should pause to reflect on the longer-term considerations in terms of international product safety, liability and insurance law issues.
COVID-19: Weekly Life Sciences Digest – PPE in EU and UK
Sarah-Jane Dobson, Edward Turtle, Harriet Jones and Julia Maskell
With COVID-19 heralding unprecedented changes in the sector, our life sciences products experts provide a weekly summary of key international developments to keep you up to date.
FSA raises bar for CBD food products
Jamie Humphreys and Emma Lidstrom
UK food safety watchdog issues warning to CBD businesses that their products could be ‘taken off the shelves’ if the industry fails to submit valid novel food authorisation applications by 31 March 2021.
COVID-19: Weekly Life Sciences Digest – Initiatives for Fast Tracking Treatments and New FDA Guidance
Phil Mitchell, Edward Turtle, Sana Shakir, Julia Maskell and Alicia Johnson-Cole
With COVID-19 heralding unprecedented changes in the sector, our life sciences products experts provide a weekly summary of key international developments to keep you up to date.
COVID-19: Weekly Life Sciences Digest – International Collaboration and New Guidance in the EU and UK
Sarah-Jane Dobson, Edward Turtle and Julia Maskell
With COVID-19 heralding unprecedented changes in the sector, our life sciences products experts provide a weekly summary of key international developments to keep you up to date.
WEBCAST: 2020 Vision – Looking Beyond COVID-19. Longer-Term Considerations for Supply and Manufacture of Products During COVID-19
Many companies are opting to rapidly pivot into new product lines or significantly increase their production volumes. In doing this, they are relying on exceptions to, and derogations from, the usual regulatory regimes, or a flexible approach to enforcement by regulatory authorities – all motivated by the unique context of COVID-19. […]
The right to be recognised, rebooted: Regulation (EU) 2019/515 on the mutual recognition of goods starts to apply
Claire Temple, Edward Turtle and Olivia Flasch
The EU’s new regulation on the mutual recognition of goods has started to apply. One part of the so-called “Goods Package”, it aims to improve the application of the mutual recognition principle for goods and remove unjustified barriers to trade within the EU.
COVID-19: Weekly Life Sciences Digest – Guidance for Industry in EU, UK and US
Natasha Leskovsek, Sarah-Jane Dobson, Edward Turtle, Harriet Jones and Julia Maskell
With COVID-19 heralding unprecedented changes in the sector, our life sciences products experts provide a weekly summary of key international developments to keep you up to date.