Regulatory Affairs, Pharmacovigilance

Guidance: Clinical trials: Phase 1, 14-Day Pilot Programme https://www.gov.uk/government/publications/clinical-trials-phase-1-14-day-pilot-programme The pilot aims to deliver the first wave 1 regulatory assessment in 14 calendar days for qualifying applications by the end of 2026.

[SHINSA]English Translation of Review Report: Beovu (Partial Change Approval) https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0001.html

Vimseltinib (romvimza) approved for use in adults to treat tenosynovial giant cell tumours https://www.gov.uk/government/news/vimseltinib-romvimza-approved-for-use-in-adults-to-treat-tenosynovial-giant-cell-tumours As with any medicine, the MHRA will keep the safety and effectiveness of vimseltinib (romvizma) under close review.

Medicines: get scientific advice from the MHRA https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.

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.

Lystralin (Vetcare Oy) http://ec.europa.eu/health/documents/community-register/html/v338.htm#proc170566 Lystralin (Active substance: finrozole) - Centralised - Variation - Commission Decision (2026) 5879 of Thu, 13 Aug 2026 - European Medicines Agency (EMA) procedure number: VNRA 358000

Docetaxel Kabi (Fresenius Kabi Deutschland GmbH) http://ec.europa.eu/health/documents/community-register/html/h770.htm#proc170774 Docetaxel Kabi (Active substance: Docetaxel) - Centralised - Yearly update - Commission Decision (2026) 5859 of Wed, 12 Aug 2026

[SHINSA]English Translation of Review Report: Optune Lua and Esprit BTK Everolimus Eluting Resorbable Scaffold System https://www.pmda.go.jp/english/review-services/reviews/approved-information/devices/0003.html

Intravascular Administration Set Recall: Baxter Removes Duo-Vent Solution Sets http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/intravascular-administration-set-recall-baxter-removes-duo-vent-solution-sets

Navigating Protocol Amendments: Understanding the Growing Burden and Charting a Path Forward https://www.wcgclinical.com/insights/navigating-protocol-amendments-understanding-the-growing-burden-and-charting-a-path-forward/

COVID-19 test approval: how to apply https://www.gov.uk/guidance/covid-19-test-approval-how-to-apply How manufacturers or distributors of Coronavirus (COVID-19) test devices can apply for approval of their tests to be placed on the UK market.

Guidance: Magnetic resonance imaging equipment in clinical use: safety guidelines https://www.gov.uk/government/publications/safety-guidelines-for-magnetic-resonance-imaging-equipment-in-clinical-use Relevant safety information for users of magnetic resonance imaging (MRI) equipment in clinical use.

You've got the grades, but don't pass on your health https://www.gov.uk/government/news/youve-got-the-grades-but-dont-pass-on-your-health Medicines and medical devices regulator issues health advice for teens off to university.

Corporate report: MHRA quarterly Results and Forecast: 2026 to 2027 https://www.gov.uk/government/publications/mhra-quarterly-results-and-forecast-2026-to-2027 Quarterly reports to provide performance information and projections across 2026/2027.

Convenience Kit Correction: Medline Issues Correction for Convenience Kits Containing ICU Medical Pain Management Components http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/convenience-kit-correction-medline-issues-correction-convenience-kits-containing-icu-medical-pain

Update on Alert: Convenience Kit Issue from Medline http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/update-alert-convenience-kit-issue-medline

MHRA reaffirms the safety of childhood vaccination https://www.gov.uk/government/news/mhra-reaffirms-the-safety-of-childhood-vaccination Vaccination is one of the most effective and safest ways to protect against many serious infectious diseases

Clinical investigations for medical devices https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.

Fresenius Kabi Issues Nationwide Recall of Tyenne® (tocilizumab-aazg) Injection 400 mg/20 mL Vials Due to Presence of Glass Particles http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-nationwide-recall-tyenner-tocilizumab-aazg-injection-400-mg20-ml-vials-due

Decision: Medicines: new manufacturing and wholesale dealer licences https://www.gov.uk/government/publications/medicines-new-manufacturing-and-wholesale-dealer-licences List of sites granted a manufacturer or wholesale dealer licence.