News, Policy & Media

Sep 17, 2020
Finding solutions to the current testing service crisis is the Government’s ‘number one’ priority, according to Justice Secretary Robert Buckland. Government priorities will be clarified in a list which is to be published in the coming days, Buckland advised. Plans around the NHS will take centre-stage in the Government’s initiatives and the solving the current testing delays will be a key challenge. Health Secretary Matt Hancock has asserted that Government is ‘wor...
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Sep 09, 2020
The Government has set out its plans for a new approach to subsidy control and state aid in the post-Brexit landscape. The UK will be following WTO subsidy rules and other international commitments from the 1st January 2021 according to Business Secretary Alok Sharma. WTO rules are an internationally recognised common standard covering financial assistance granted by governments and public authorities to companies. The UK has been following the EU state aid rules up until now, these are managed ...
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Sep 07, 2020
 The House of Lords held its second reading of the Medicines and Medical Devices Bill last Thursday, with Innovation Minister Lord Bethell of Romford bringing the Bill before the House. The minister stated that the text is crucial to ‘the development of a modern, safe, medical regulation regime’ which will ensure patient safety is guaranteed and lives are saved into the future. Safety is the at the heart of the Bill’s mission, with medical devices tracking approaches and i...
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Sep 03, 2020
The DHSC hosted a Brexit Readiness Webinar on 27th August 2020 - if you were unavailable to attend you might find the attachments and links useful.  By way of follow up, please find below the following: the slides presented by HMRC (attached); slides on how medical suppliers can prepare to be ‘Trader Ready’ for the end of the Transition Period (attached); importing and exporting ‘decision trees’, as referenced by Tony Thomas from the Border and Protocol Delivery Grou...
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Sep 02, 2020
 The Medicines and Healthcare Products Regulatory Agency (MHRA) has released new guidance on the regulatory arrangements for medical devices after the end of the Transition Period (January 2021). Three key aspects are emphasized in the new information. Firstly, the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) will not take effect in the UK after the end of the Transition Period, only in EU member states. They will apply from the 26 May 2021 and 26 May 2022 ...
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Sep 02, 2020
UK-Japan Free Trade talks near completion   The UK-Japan Free Trade Agreement trade talks are entering their final stage of negotiations. The pace of talks has accelerated ahead of a notional deadline of September set out by Japan. Substantial progress has been made during two days of talks this month between UK and Japanese negotiators in London.   The talks form part of the push for international trade deals to be secured by the UK in advance of the end of the Tran...
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Aug 27, 2020
Stephen Lightfoot has been appointed as the Agency’s new Chair from 1st September 2020. He succeeds Prof Sir Michael Rawlins GBE, Kt who has been the Chair of the Agency Board since December 2014.Stephen has been a Non-Executive Director of the Agency since September 2015 and is also Deputy Chair of Sussex Community NHS Foundation Trust and Non-Executive Chair of Sussex Primary Care Limited.Before joining the Board, Stephen had a 30-year career in the life sciences industry working on the ...
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Aug 25, 2020
The U.S Department of Health and Human Services has issued a decision stating that the Federal Drug Association (FDA) will no longer require a premarket review of lab-developed tests during the COVID-19 pandemic. This move means that requirements are based on notice-and-comment rulemaking versus guidance documents, compliance manuals, website statements or other informal issuances. The decision comes in the midst of an apparent rift between HHS Secretary Alex Azar and FDA Commissioner Stephen Ha...
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Aug 19, 2020
The Government’s national testing study is due to be expanded with a rise in fortnightly testing from 28,000 to 150,000 by October. It was announced today that the Office for National Statistics (ONS) intends to significantly expand its survey, growing the number of participants to 400,000 in England. Such an increase will make it the largest study tracking COVID-19 infections in the general population. It is expected that key insights will be taken from the widened study, these will feed ...
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Aug 18, 2020
 The Government has today announced the creation of the National Institute for Health Protection (NIHP). The organisation will be responsible for public health protection, infectious disease control and leading the UK's future COVID-19 response through a single-command structure. This comes as the disbanding of Public Health England was confirmed by Health and Social Care Secretary Matt Hancock. NIHP will be an amalgam of PHE's COVID-19 response team and the NHS Test and Trace Progr...
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