tag:www.gov.uk,2005:/government/organisations/medicines-and-healthcare-products-regulatory-agency HM Government 2025-05-15T10:30:20Z /drug-safety-update/thiopurines-and-intrahepatic-cholestasis-of-pregnancy#2025-05-15T10:30:20Z 2025-05-15T10:30:20Z

Intrahepatic cholestasis of pregnancy (ICP) has been rarely reported in patients treated with azathioprine products and is believed to be a risk applicable to all drugs in the thiopurine class (azathioprine, mercaptopurine and tioguanine). Cholestasis of pregnancy associated with thiopurines tends to occur earlier in pregnancy than non drug-induced cholestasis of pregnancy, and elevated bile acid levels may not reduce with ursodeoxycholic acid.

/guidance/register-a-homeopathic-medicine-or-remedy#2025-05-14T16:09:31Z 2025-05-14T16:09:31Z

Information about how to register your homeopathic medicinal product through the Simplified Homeopathic Registration Scheme or the UK Homeopathic National Rules Scheme

/government/publications/advertising-investigations-april-2025#2025-05-14T13:53:59Z 2025-05-14T13:53:59Z

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

/government/publications/medical-devices-given-exceptional-use-authorisations-during-the-covid-19-pandemic#2025-05-14T07:55:23Z 2025-05-14T07:55:23Z

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-5-to-8-may-2025#2025-05-14T07:47:13Z 2025-05-14T07:47:13Z

List of Field Safety Notices from 5 to 8 May 2025.

/government/publications/orphan-registered-medicinal-products#2025-05-13T11:26:11Z 2025-05-13T11:26:11Z

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

/drug-device-alerts/class-4-medicines-notification-chemidex-pharma-ltd-various-products-el-25-a-slash-21#2025-05-13T10:00:04Z 2025-05-13T10:00:04Z

Chemidex Pharma Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in their topical steroid products does not contain all the required safety information. Cartons for the products/batches listed are missing side effect information related to Visual Disturbances.

/government/publications/parallel-import-licences-granted-in-2025#2025-05-13T08:50:33Z 2025-05-13T08:50:33Z

Parallel import licences granted in 2025.

/government/publications/international-recognition-procedure#2025-05-13T08:37:02Z 2025-05-13T08:37:02Z

How to use the procedure for medicines licensing applications.

/government/publications/marketing-authorisations-granted-in-2025#2025-05-13T08:36:22Z 2025-05-13T08:36:22Z

Marketing authorisations granted in 2025.

/government/news/meet-the-women-helping-ensure-that-digital-mental-health-technologies-are-safe-effective-and-developed-considering-the-needs-of-the-people-who-use-th#2025-05-12T23:00:00Z 2025-05-12T23:00:00Z

Mental health apps are everywhere, offering everything from mood tracking to therapy. But with so many options, how can people tell what these tools actually do?

/government/news/mhra-approves-first-uk-treatment-for-congenital-thrombotic-thrombocytopenic-purpura-cttp#2025-05-12T16:41:15Z 2025-05-12T16:41:15Z

As with all products, the MHRA will keep its safety under close review.

/guidance/medicines-apply-for-a-parallel-import-licence#2025-05-12T15:22:24Z 2025-05-12T15:22:24Z

How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.

/government/consultations/consultation-on-the-international-council-for-harmonisation-ich-e6-r3-guideline-for-good-clinical-practice-annex-2#2025-05-12T13:25:48Z 2025-05-12T13:25:48Z

The ICH Expert Working Group for ICH E6(R3) (EWG) has been updating the ICH E6(R2) GCP guideline. The MHRA represents the Pharmaceutical Inspection Co-operation Scheme (PIC/s) in the EWG.

/government/news/mhra-approves-worlds-first-low-carbon-version-of-copd-inhaler-trixeo-aerosphere#2025-05-12T04:17:30Z 2025-05-12T04:17:30Z

As with all medicines, the MHRA will continue to monitor the safety and effectiveness of Trixeo Aerosphere

/government/publications/the-northern-ireland-mhra-authorised-route-nimar#2025-05-09T10:14:01Z 2025-05-09T10:14:01Z

The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.

/government/consultations/consultation-on-the-international-council-for-harmonisation-ich-m13b-guideline-on-bioequivalence-for-immediate-release-solid-oral-dosage-forms#2025-05-08T23:01:00Z 2025-05-08T23:01:00Z

The ICH Expert Working Group (EWG) for ICH M13B has been drafting the second guideline in the series which describes the scientific and technical aspects of study design and data analysis to support bioequivalence (BE) assessment for orally administered immediate-release solid oral dosage forms.

/government/publications/medicines-and-healthcare-products-regulatory-agency-gpc-spending-over-500-2024-25#2025-05-08T16:23:57Z 2025-05-08T16:23:57Z

MHRA transactions over £500 made using the government procurement card (GPC).

/government/publications/medicines-and-healthcare-products-regulatory-agency-gpc-spending-over-500-2023-24#2025-05-08T16:23:56Z 2025-05-08T16:23:56Z

MHRA transactions over £500 made using the government procurement card (GPC).

/government/publications/medicines-and-healthcare-products-regulatory-agency-gpc-spending-over-500-2022-23#2025-05-08T16:23:55Z 2025-05-08T16:23:55Z

MHRA transactions over £500 made using the government procurement card (GPC).