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Industry Newsletters Regulatory Affairs Newsletter Archive

Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

SHEILD up! Launch of EUR 25 million project to prevent infections from developing into cancer

SHEILD up! Launch of EUR 25 million project to prevent infections from developing into cancer Every year, more than two million people in Europe develop cancer, and one in eight of these cancer cases are caused by an infection that could have been prevented. The SHEILD Joint Action (Strategies for Health Interventions to Eliminate Infection related Cancers) launched today in…
Ben Kemp
January 12, 2026
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Open Licence Annual Returns for 2025

Exporters holding certain Open General Licences (OGLs) will have received automatic requests from SPIRE to complete their annual returns for 2025. Before you submit your return, check the following: Select the correct reporting period (01-JAN-25 to 31-DEC-25) • Usage count must be entered accurately. • Surrender any licences no longer in use after submitting returns. The Open Licence Returns guidance…
Ben Kemp
January 12, 2026
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Report issues with medicines and medical devices to help make them safer

Dear members, TGA - Australia are promoting the Reporting of  issues with medicines and medical devices to help make them safer. Have you experienced an issue with a medicine or medical device? Every report is important. Reports help us monitor the safety of medicines, vaccines and medical devices. View article...
Ben Kemp
December 12, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

BSI: Privacy has changed are you ready?

Privacy has changed. Are you ready? November 2025 Stay ahead in Digital Trust with One Click Closer. With ISO/IEC 27701 now published as a stand-alone standard, marking the growing maturity of privacy as a discipline, this month we focus on transforming privacy commitments into confident, practical action. Privacy can’t be an afterthought. People want clarity. Regulators want evidence. Organizations need…
Ben Kemp
December 10, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Health Canada IMDRF table of contents for medical device applications guidance

Dear Members, please see below update that Health Canada has adopted the IMDRF Table of Contents format for medical device applications. Health Canada has adopted the International Medical Device Regulators Forum table of contents format o encourage and support the global convergence of medical device applications. View article...
Ben Kemp
December 10, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Windows 10 end of support: Potential impact on medical devices

Dear members, please see below TGA post regarding Windows 10 end of support: Potential impact on medical devices. It doesn’t take into account LTSC Enterprise licences (End of support 12 Jan 2027) or Enterprise IoT licences which have an end of support scheduled in 2032. Some medical devices could be affected by the end of support for the Microsoft Windows…
Ben Kemp
December 10, 2025
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