Regulatory Affairs, Pharmacovigilance

Decision: Medical devices given exceptional use authorisations https://www.gov.uk/government/publications/medical-devices-given-exceptional-use-authorisations List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.

Field Safety Notices: 31 August to 4 September 2026 https://www.gov.uk/drug-device-alerts/field-safety-notices-31-august-to-4-september-2026 List of Field Safety Notices from 31 August to 4 September 2026.

Decision: Human medicines: register of electronic export certificates https://www.gov.uk/government/publications/human-medicines-register-of-electronic-export-certificates Department of Health and Social Care and MHRA register of electronic export certificates (human).

Decision: Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients https://www.gov.uk/government/publications/suspended-licences-for-manufacturers-and-wholesalers-of-medicines Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended.

Decision: Advertising investigations: August 2026 https://www.gov.uk/government/publications/advertising-investigations-august-2026 Decisions made by MHRA on adverts reported to have breached the legislation on advertising medicines.

Guidance: Medicines that you cannot export from the UK or hoard https://www.gov.uk/government/publications/medicines-that-cannot-be-parallel-exported-from-the-uk Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.

[IBENTO][IBENTO]Report on the PMDA Hokuriku Branch 10th Anniversary Symposium https://www.pmda.go.jp/english/symposia/0364.html

BMC Medical Co., Ltd. Recalls Luna G3 APAP (Model LG3600) with Firmware G3-2.00.76 Due to Firmware Defect http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bmc-medical-co-ltd-recalls-luna-g3-apap-model-lg3600-firmware-g3-20076-due-firmware-defect

[YAKKYOKUKATA]JP Drafts (September 2026) Part 2 posted https://www.pmda.go.jp/english/rs-sb-std/standards-development/jp/pub-comments/jp/0053.html

[YAKKYOKUKATA]JP Drafts (September 2026) Part 1 posted https://www.pmda.go.jp/english/rs-sb-std/standards-development/jp/pub-comments/jp/0054.html

RUNX2 inhibitor CADD522 improves bone microarchitecture and lipid metabolism in post-menopausal bone loss https://www.nature.com/articles/s44386-026-00076-z

Body composition-mediated and drug-related metabolic dysregulation during long-term antipsychotic treatment in youth https://www.nature.com/articles/s44220-026-00721-6

Symtuza (Janssen-Cilag International NV) http://ec.europa.eu/health/documents/community-register/html/h1225.htm#proc170455 Symtuza (Active substance: darunavir / cobicistat / emtricitabine / tenofovir alafenamide) - Centralised - Variation - Commission Decision (2026) 6295 of Thu, 03 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/X/0000248421

Zimbus Breezhaler (Novartis Europharm Limited) http://ec.europa.eu/health/documents/community-register/html/h1440.htm#proc170886 Zimbus Breezhaler (Active substance: indacaterol / glycopyrronium bromide / mometasone) - Centralised - Yearly update - Commission Decision (2026) 6287 of Thu, 03 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/YU/0000363394

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Decision: Human medicines: register of licensed wholesale distribution sites https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-wholesale-distribution-sites Department of Health and Social Care and MHRA register of licensed wholesale distribution sites (human).

IND Safety Reporting: What Sites Need to Submit https://www.wcgclinical.com/insights/ind-safety-reporting-what-sites-need-to-submit/

Decision: Marketing authorisations Granted in 2026 https://www.gov.uk/government/publications/marketing-authorisations-granted-in-2026 Marketing authorisations granted in 2026.

Decision: Parallel import licences granted in 2026 https://www.gov.uk/government/publications/parallel-import-licences-granted-in-2026 Parallel import licences granted in 2026.