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Ben Kemp

Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates – WC 19th January

Notices made under The Customs (Import Duty) (EU Exit) Regulations 2018 Page summary: Notices made under The Customs (Import Duty) (EU Exit) Regulations 2018 which have the force of law. Change made: The ‘Notice made under Regulation 89(5A) of The Customs (Import Duty) (EU Exit) Regulations 2018’ has been updated for conditions of authorisation that apply where declared goods are,…
Ben Kemp
January 23, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates – WC 19th January

Clinical trials that include an in vitro diagnostic device Page summary: Guidance on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device. Change made: Clarified documentation requirements where the device is not UKCA or CE marked, and the health institution exemption does not apply. Created publication ‘Figure 1. Application process for clinical trials…
Ben Kemp
January 23, 2026
ConsultationsConsultations ArchiveMembership NewsMembership News Archive

New NICE consulation: Statement of intent on NICE’s approach to ongoing evaluations ahead of proposed changes to NICE’s standard cost-effectiveness thresholds

Following the closure of NICE's consultation of ministerial intervention into their cost-effectiveness thresholds, the organisation has released a further consultation on their statement of intent to ongoing evaluations. For reference, NICE uses cost-effectiveness thresholds in health economic evaluations to determine whether health technologies represent value for money for use in the NHS in England. Subject to parliamentary approval, DHSC processes…
Ben Kemp
January 21, 2026
Membership NewsMembership News Archive

Helen attends health innovation roundtable with Health and Science Ministers

On Tuesday, BIVDA Chief Executive Helen Dent attended a roundtable focused on health innovation with Health Minister, Zubir Ahmed and Science Minister, Lord Vallance. Several other major government figures with life science interests were also in attendance, including Steve Bates, Executive Chair, OLS; Dr Axel Heitmuller, Head of the PM's Delivery Unit; Dr Penny Dash, Chair, NHS England; David Lawson,…
Ben Kemp
January 21, 2026
HighlightsHighlights Archive

Media Monitoring: 7th – 21st January

  New European initiative seeks to accelerate timely Alzheimer's disease diagnosis and treatment The ACCESS-AD consortium, which is co-led by King’s College London, Amsterdam UMC, Siemens Healthineers and Gates Ventures, and funded by the European Commission’s Innovative Health Initiative, has announced the launch of a transformative European initiative which has an initial budget of over €38 million over 5 years…
Ben Kemp
January 20, 2026
Membership NewsMembership News Archive

The North East Pharma, HealthTech and Life Sciences barometer survey

Square One Law, in partnership with CPI, is launching the second annual survey to understand the current pulse of the health and life sciences sector across North East England. Building on last year’s insights, this survey will form part of a yearly series that tracks how the regional ecosystem is evolving and where support is most needed. If your organisation…
Ben Kemp
January 20, 2026
Membership NewsMembership News Archive

ROK-UK Smart Clinical Trials Application Development Award now open

  The ROK-UK Smart Clinical Trials Application Development Award opened last week. It is a NIHR partnership with the Korea Health Industry Development Institute (KHIDI) to support UK and Republic of Korea (ROK) researchers working together on developing and using new tools and technologies to deliver ‘Smart’ clinical trials. These are clinical trials that leverage innovative technologies and methodologies to…
Ben Kemp
January 20, 2026
Membership NewsMembership News Archive

Webinar: Unlocking the Saudi Biotech Opportunity: A New Frontier for UK Biotech Companies

The Department for Business and Trade at the British Embassy in Riyadh, in collaboration with the Ministry of Health and BIO Middle East, invite our members to attend an upcoming webinar which will provide valuable insights into the opportunities within Saudi Arabia’s thriving biotech market. Date and time: Tuesday 27th January, 10am - 11am Saudi Arabia is rapidly emerging as…
Ben Kemp
January 20, 2026
Membership NewsMembership News Archive

G&H announced as new BIVDA members

BIVDA are delighted to announce that G&H (Gooch & Housego) are now BIVDA members. G&H is a global leader in optical design, testing, and manufacturing. Headquartered in Ilminster, UK, with sites in the UK and USA, G&H delivers advanced photonic components and systems for life sciences, industrial, and defence applications. Specific to our sector, they focus on medical device design,…
Ben Kemp
January 20, 2026
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