tag:www.gov.uk,2005:/government/organisations/medicines-and-healthcare-products-regulatory-agency HM Government 2025-06-26T14:23:59Z /government/publications/review-of-risk-minimisation-for-disabling-and-potentially-long-lastingirreversible-side-effects-associated-with-fluoroquinolone-antibiotics#2025-06-26T14:23:59Z 2025-06-26T14:23:59Z

Public Assessment Report on the review of risk minimisation for fluoroquinolone antibiotics.

/government/news/if-you-take-a-glp-1-medicine-and-have-been-hospitalised-by-acute-pancreatitis-the-yellow-card-biobank-wants-to-hear-from-you#2025-06-26T08:56:22Z 2025-06-26T08:56:22Z

GLP-1 medicines are licensed for Type 2 diabetes and weight management, and include the branded products Ozempic, Mounjaro and Wegovy 

/government/news/mhra-seizes-77-million-doses-of-illegal-medicines-and-removes-hundreds-of-illegal-online-listings-as-part-of-operation-pangea#2025-06-25T16:14:02Z 2025-06-25T16:14:02Z

Operation Pangea brings together health regulators, customs authorities, law enforcement agencies, and private sector partners to tackle the threat posed by global criminal networks

/drug-device-alerts/class-2-medicines-recall-depo-medrone-80-mg-in-2-ml-maxearn-limited-el-25-a-slash-29#2025-06-25T13:00:03Z 2025-06-25T13:00:03Z

A batch of Depo-Medrone has been released to the market with an error. The vial over label incorrectly states that the total vial content is 40 mg in 1 mL, when the correct total vial content is 80mg in 2 mL (with a concentration of 40mg/ml of methylprednisolone acetate).

/government/publications/medicines-variation-forms-for-a-manufacturer-licence#2025-06-25T11:16:54Z 2025-06-25T11:16:54Z

Forms to make a variation to a manufacturer's licence.

/government/news/mhra-publishes-final-business-plan-for-2023-2026-corporate-plan#2025-06-25T10:10:09Z 2025-06-25T10:10:09Z

The new Business Plan sets out priorities for 2025–26: Protecting public safety and maintaining public trust; delivering efficient, predictable services through regulatory excellence; being an agile organisation that drives innovation; being a great place to work and providing excellent customer service. 

/government/publications/mhra-corporate-plan-2023-to-2026#2025-06-25T10:00:02Z 2025-06-25T10:00:02Z

These reports outline the MHRA’s Corporate and Business Plans, detailing the agency's strategic direction over the next three years.

/drug-device-alerts/class-3-medicines-recall-kimmtrak-200-micrograms-slash-ml-concentrate-for-solution-for-infusion-immunocore-limited-el-25-a-slash-28#2025-06-25T09:48:31Z 2025-06-25T09:48:31Z

Immunocore Limited is recalling the batches listed below as a precautionary measure. The recall is due to a decrease in potency identified during stability testing. All other stability test results remain within specification.

/guidance/clinical-trials-for-medicines-collection-verification-reporting-of-safety-events#2025-06-25T09:07:14Z 2025-06-25T09:07:14Z

Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.

/guidance/clinical-trials-non-investigational-medicinal-products#2025-06-25T09:07:13Z 2025-06-25T09:07:13Z

Guidance on using non-investigational medicinal products in a clinical trial.

/guidance/clinical-trials-regulations-transitional-arrangements#2025-06-25T09:07:12Z 2025-06-25T09:07:12Z

Guidance on transitional arrangements for applying for clinical trial approval.

/guidance/clinical-trials-for-medicines-modifying-a-clinical-trial-approval#2025-06-25T09:07:11Z 2025-06-25T09:07:11Z

Guidance on the various types of modifications that can be made to a clinical trial approval.

/guidance/clinical-trials-for-medicines-ending-a-clinical-trial#2025-06-25T09:07:11Z 2025-06-25T09:07:11Z

Guidance on the process for ending a clinical trial.

/guidance/clinical-trials-for-medicines-notifiable-trials#2025-06-25T09:07:10Z 2025-06-25T09:07:10Z

Guidance on categorising certain clinical trials as ‘notifiable’.

/guidance/clinical-trials-for-medicines-labelling#2025-06-25T09:07:09Z 2025-06-25T09:07:09Z

Guidance on labelling for medicinal products used in clinical trials.

/guidance/clinical-trials-for-medicines-expert-advice#2025-06-25T09:07:09Z 2025-06-25T09:07:09Z

Clinical trial applications that need expert advice from a specialist group or committee.

/guidance/clinical-trials-for-medicines-apply-for-approval-in-the-uk#2025-06-25T09:07:08Z 2025-06-25T09:07:08Z

How to apply for a clinical trial from 28 April 2026, including eligibility, phases, model IMPDs, costs and how to make changes to your application.

/drug-device-alerts/field-safety-notices-16-to-20-june-2025#2025-06-24T16:55:25Z 2025-06-24T16:55:25Z

List of Field Safety Notices from 16 to 20 June 2025.

/government/publications/medicines-and-healthcare-products-regulatory-agency-spending-over-25000-2025-to-2026#2025-06-24T15:44:47Z 2025-06-24T15:44:47Z

Information on Medicines and Healthcare products Regulatory Agency spending over £25,000.

/government/publications/medicines-and-healthcare-products-regulatory-agency-spending-over-25000-2024-to-2024#2025-06-24T14:52:25Z 2025-06-24T14:52:25Z

Information on Medicines and Healthcare products Regulatory Agency spending over £25,000.