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EFLM – Direct-to-consumer testing as consumer initiated testing: compromises to the testing process and opportunities for quality improvement

The EFLM Task Force "Direct-to-Consumer Testing" has published the following scientific paper: Direct-to-consumer testing as consumer initiated testing: compromises to the testing process and opportunities for quality improvement. You can access it here.
Ben Kemp
September 4, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Update

Philippines: UK Science & Innovation Network Summary Page summary: A summary from UK Science and Innovation Network (SIN) on science and innovation in the Philippines including UK SIN priorities and successes. Change made: First published. Time updated: 10:01am, 28 August 2024 Responsible AI Toolkit Page summary: Toolkit for practitioners to support the responsible use of AI systems. Change made: Added…
Ben Kemp
September 4, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Update (WC 2 Sept)

DBT national survey of registered businesses’ exporting behaviours, attitudes and needs Page summary: Insights on UK companies’ views of exporting, including perceptions around trade barriers. Change made: DBT national survey of registered businesses’ exporting behaviours, attitudes and needs 2023 added to collection page. Time updated: 9:30am, 29 August 2024 DBT national survey of registered businesses’ exporting behaviours, attitudes and needs…
Ben Kemp
September 4, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates (WC 2 Sept)

Notify MHRA about a clinical investigation for a medical device Page summary: Information on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Change made: Updated to include new QSR template Time updated: 11:09am, 27 August 2024   MHRA consultation on statutory fees – proposals on ongoing cost recovery Page summary: Consultation…
Ben Kemp
September 4, 2024
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA launch statutory fees consultation

The MHRA last week launched a consultation on statutory fees proposals for April 2025 until March 2027. Unsurprisingly, the trajectory is upwards - in some cases (such as clinical trials) significantly. BIVDA’s Head of Policy and Programmes, Paul Fisher noted, "These proposed increases will disproportionately impact SMEs - the sector that the government and NHS recognise as a key part…
Ben Kemp
September 3, 2024