tag:www.gov.uk,2005:/government/organisations/medicines-and-healthcare-products-regulatory-agency HM Government 2026-05-15T18:09:20Z /government/news/mhra-approves-beremagene-geperpavec-vyjuvek-for-the-treatment-of-dystrophic-epidermolysis-bullosa#2026-05-15T18:09:20Z 2026-05-15T18:09:20Z

As with any medicine, the MHRA will keep the safety and effectiveness of Vyjuvek under close review.

/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device#2026-05-14T14:58:59Z 2026-05-14T14:58:59Z

How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.

/drug-device-alerts/class-4-medicines-defect-notification-fresenius-medical-care-deutschland-gmbh-balance-2-dot-3-percent-glucose-1-dot-25-mmol-slash-l-calcium-solution-for-peritoneal-dialysis-el-26-a-slash-24#2026-05-14T09:59:11Z 2026-05-14T09:59:11Z

Fresenius Medical Care Deutschland GmbH have identified an error in the Braille printed on the outer label.

/government/publications/orphan-registered-medicinal-products#2026-05-13T12:46:14Z 2026-05-13T12:46:14Z

A list of authorised orphan medicinal products registered by the UK licensing authority.

/guidance/medical-devices-conformity-assessment-and-the-ukca-mark#2026-05-13T12:38:36Z 2026-05-13T12:38:36Z

How to conform with the legal requirements for placing medical devices on the market.

/guidance/medicines-pipeline-data#2026-05-13T10:43:35Z 2026-05-13T10:43:35Z

Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.

/government/news/mhra-supports-northern-ireland-life-sciences-sector-with-new-hub#2026-05-13T10:37:27Z 2026-05-13T10:37:27Z

The MHRA hub in Belfast will strengthen collaboration and engagement with local industry, academia and the healthcare sector.

/guidance/medical-devices-ask-for-a-regulatory-advice-meeting-from-the-mhra#2026-05-13T10:09:38Z 2026-05-13T10:09:38Z

How to apply for a regulatory advice meeting on medical devices and in vitro diagnostic devices.

/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine#2026-05-12T16:29:40Z 2026-05-12T16:29:40Z

How the MHRA makes decisions on what is a medicinal product (borderline products).

/drug-device-alerts/field-safety-notices-27-april-to-1-may-2026#2026-05-12T14:15:24Z 2026-05-12T14:15:24Z

List of Field Safety Notices from 27 April to 1 May 2026.

/government/publications/medical-devices-given-exceptional-use-authorisations#2026-05-12T12:48:53Z 2026-05-12T12:48:53Z

List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.

/drug-device-alerts/field-safety-notices-4-to-8-may-2026#2026-05-12T12:46:01Z 2026-05-12T12:46:01Z

List of Field Safety Notices from 4 to 8 May 2026.

/government/news/mhra-strengthens-safety-warnings-for-finasteride-and-dutasteride#2026-05-11T13:43:56Z 2026-05-11T13:43:56Z

Updated safety advice has been issued to strengthen warnings about potential psychiatric and sexual dysfunction linked to finasteride and to provide precautionary advice on dutasteride.

/drug-safety-update/finasteride-and-dutasteride-updated-safety-warnings-for-psychiatric-side-effects-and-sexual-dysfunction#2026-05-11T13:29:47Z 2026-05-11T13:29:47Z

The MHRA has reviewed the evidence for finasteride and dutasteride and the risk of suicidal thoughts and behaviours and has recommended further measures to minimise this risk.

/government/news/mhra-opens-uk-wide-consultation-on-redefining-gene-therapies#2026-05-11T13:00:52Z 2026-05-11T13:00:52Z

To future-proof the sector and ensure regulation keeps up with scientific and technological developments, the MHRA is consulting on proposed changes to how gene therapies are defined in UK legislation.

/government/news/mhra-invites-views-on-proposed-changes-to-medical-device-regulation#2026-05-11T10:26:00Z 2026-05-11T10:26:00Z

New pre-market regulatory requirements for medical devices and in vitro diagnostic devices entering the GB market have been published.

/drug-device-alerts/class-4-medicines-defect-notification-milpharm-limited-loperamide-hydrochloride-2-mg-orodispersible-tablets-el-26-a-slash-23#2026-05-11T10:02:32Z 2026-05-11T10:02:32Z

Milpharm Limited has identified a discrepancy in the Patient Information Leaflet (PIL) approved for Loperamide hydrochloride 2 mg Orodispersible Tablets.

/government/calls-for-evidence/pre-market-medical-devices-regulation-stakeholder-impact-survey#2026-05-11T09:25:55Z 2026-05-11T09:25:55Z

MHRA seeks stakeholder evidence on proposed GB pre-market medical device/IVD regulation changes to inform impact assessment; deadline 11:59pm Fri 19 Jun 2026.

/government/consultations/consultation-on-the-regulation-of-gene-therapy-medicinal-products#2026-05-11T08:00:03Z 2026-05-11T08:00:03Z

We are seeking views on proposed updates to the definition of Gene therapy medicinal products to better reflect advances in science and manufacturing.

/government/news/mhra-delivers-its-targets-to-increase-access-to-medicines-and-reinforce-uk-position-as-a-global-destination-for-life-sciences#2026-05-08T13:26:41Z 2026-05-08T13:26:41Z

The MHRA continues to speed up access to medicines for patients, increase efficiency of regulation and help to attract innovation and investment in the UK’s thriving £100 billion life sciences industry.