Inside Life Sciences

Issue 12

Editor's Note

Welcome to the Autumn edition of Inside Life Sciences.

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Post-Brexit – The Licensing of Biosimilar Products in the UK

On 7 October, the MHRA issued a consultation document setting out its proposed guidance on the licensing and regulation of biosimilar products in the UK.

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MHRA guidance on post-transition Brexit regulation of medical devices.

With the end of the transition period looming, and the UK/EU still in discussions in relation to a possible trade deal, the UK Government has published guidance in relation to the requirements for placing medical devices on the market in Great Britain (England, Scotland and Wales), Northern Ireland and the EU after 1 January 2021.

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Clinical Trials after the end of the Brexit transition period

Since 1 February 2020, the UK has withdrawn from the EU and become a 'third country'. Until the end of the transition period (31 December 2020), EU law still applies in the UK.

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European Court finds that CBD is not a narcotic

The European Court of Justice has ruled that a particular form of CBD, derived from industrial hemp, is not a narcotic as “it does not appear to have any psychotropic effect or any harmful effect on human health”. This judgment from the EU's highest court is undoubtedly positive for the CBD industry.

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EMA encourages transparency through new monthly report on COVID-19 medicines and vaccines

In a bid to support the ongoing assessment, monitoring and transparency of medicines and vaccines in the fight against the spread of COVID-19, the European Medicines Agency (EMA) is publishing a monthly report detailing scientific advice and informal consultation details relating to COVID-19 medicines and vaccines reviewed by the COVID-19 EMA pandemic Task Force.

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An 'essential' new role for the CMA in pharma pricing?

In October 2020, the Competition & Markets Authority (CMA) announced an abuse of dominance investigation into Essential Pharma in relation to the first-line bipolar disorder treatment, Priadel.

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Pharmaceutical companies going "green" - what exactly does this mean?

Global businesses now recognise that going "green" means doing more than tackling single use plastics and reducing waste.

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When is wearable technology considered a medical device?

In recent years, the wearable technology sector has boomed, particularly in fitness wearables and medical health trackers.

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HMRC bulletin indicates that changes to IR35 legislation will be implemented in April 2021

HMRC has told businesses to prepare for the implementation of the IR35 legislation in April 2021 having delayed implementation from April 2020 as a result of the COVID-19 crisis.

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Protecting Machine Learning Data from Cybercriminals

As any organisation in the sector will know, data is at the very core of Life Sciences.

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ICO Innovation Hub and the MHRA

The Information Commissioner's Office (ICO) set up the Regulator's Business Innovation Privacy Hub (the Innovation Hub) in November 2018 to provide, in partnership with other regulators, expert support to businesses in information privacy and data protection.

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