Dear Members, CLSI have published a new standard for evaluation of external transport systems. This is a laboratory focused standard. PRE06 | Evaluation of External Transport Systems Abstract CLSI PRE06—Evaluation of External Transport Systems describes processes for evaluating an external transport system. Specimens are commonly transported from external, off-site locations to the laboratory, where they are eventually examined. The system…
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March 5, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
Your latest One IPO Patent Service update!
The One IPO Patent Service is launching on 31 March 2026. Here are the latest updates to keep our patent customers informed: What to expect when the One IPO Patent Service launches Today we have published an update on what our patent customers can expect as we approach the launch of the new service on 31 March. Find out more:…
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March 5, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
Considerations for the selection of IMDRF Adverse Event Terminology – A Guide for Industry Partners and Healthcare Providers
Dear Members, IMDRF have issued Industry guidance on the considerations for the selection of IMDRF Adverse Event Terminology N86: Final 2026 It includes examples of which 8, 12 and 18 are specific to IVDs. Considerations for the selection of IMDRF Adverse Event Terminology – A Guide for Industry Partners and Healthcare Providers View article...
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March 2, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
NEW updated type 2 diabetes guidance
You can find the update here.
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March 2, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
Now Published: CLSI C65 | Biochemical Tumor Markers
New Publication! Strengthen Tumor Market Testing with CLSI C65 Biochemical tumor marker plays a critical role in diagnosis, monitoring, and clinical decision making. With increasing pressure on laboratories to ensure accuracy and consistency across preexamination, examination, and postexamination processes, the new CLSI C65 standard provides the guidance needed to reduce risk and improve confidence in patient results. Practical…
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March 2, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
Regulation as an Enabler of Innovation: A Regional Perspective
You can find Richard Stubbs' article here.
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February 27, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
New resources on market actions and minor PRAC updates
Dear Members, TGA Australia have issued New resources on market actions and minor PRAC updates We have published a new FAQ and Guidance page on the use of legislative powers related to recalls and other market actions. View article...
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February 27, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
Use of legislative powers related to recalls and other market actions
Dear Members, TGA Australia have issued an update on use of legislative powers related to recalls and other market actions Guidance to help sponsors understand the legislative powers the TGA can use relating to market actions. View article...
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February 27, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
WHO Position Note on Accessories
Dear Members, WHO has issued a Position Note on Accessories Position Note on Accessories Published | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control) This provides guidance regarding accessories supplied with WHO Pre-Qualified Devices.
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February 27, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
NICE – Statement of intent – NICE’s approach ongoing evaluations ahead of proposed changes to NICE’s standard cost-effectiveness thresholds
Dear members, please see below update from NICE - Statement of intent - NICE's approach ongoing evaluations ahead of proposed changes to NICE's standard cost-effectiveness thresholds. Overview | Statement of intent on NICE’s approach to ongoing evaluations ahead of proposed changes to NICE’s standard cost-effectiveness thresholds | Guidance | NICE
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February 27, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
From Dialogue to Action: A Month of Global Engagement
You can find the update here.
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February 26, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
Consultation: TGA Annual Charge Exemption (ACE) Scheme Compliance Program Updates proposal 2026-27
Consultation: TGA Annual Charge Exemption (ACE) Scheme Compliance Program Updates proposal 2026-27 We have opened a consultation to provide industry and other interested stakeholders with an opportunity to comment on the our proposed updates to the ACE Scheme Compliance Program View article...
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February 26, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
TGA Guidance – Complying with Unique Device Identification requirements for medical devices
TGA have updated their UDI requirements guidance - https://www.tga.gov.au/resources/guidance/complying-unique-device-identification-requirements-medical-devices
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February 26, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
UKRI strategy builds on UK’s strength and potential in AI
UKRI strategy builds on UK's strength and potential in AI In its first AI strategy, UKRI sets out a bold plan to build on the UK’s incredible strengths and potential in areas including explainable AI, edge computing, human-in-the-loop systems, agentic AI and sustainable AI systems. The strategy will turn AI research into practical benefits for people – from real-world…
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February 20, 2026 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
CELEX:32026R0382: Council Regulation (EU) 2026/382 of 11 February 2026 amending Regulation (EC) No 1186/2009 as regards the elimination of the threshold-based customs duty relief
Dear Members, if you make shipments to the EU, please see the revised EU threshold-based customs duty relief below. CELEX:32026R0382: Council Regulation (EU) 2026/382 of 11 February 2026 amending Regulation (EC) No 1186/2009 as regards the elimination of the threshold-based customs duty relief for shipments with intrinsic value not exceeding €150.00 View article...
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February 20, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
Health Technology Assessment: HTA Coordination Group publishes its 2025 Annual Report
Health Technology Assessment: HTA Coordination Group publishes its 2025 Annual Report The Member State Coordination Group on Health Technology Assessment (HTACG) has published its 2025 Annual Report, providing an overview of the first year of application of the EU Health Technology Assessment Regulation. The report presents the key achievements of the HTACG and its four subgroups in 2025, covering joint…
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