GovWire

MHRA performance metrics for clinical trials and established medicines assessment.

A suite of guidance has been published by the Medicines and Healthcare products Regulatory Agency (MHRA).

A roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices and an intended policy on international recognition.

How to report adverse incidents involving insulin infusion pumps and integrated meter systems under the vigilance system.

How to report adverse incidents involving cardiac ablation devices under the vigilance system.

Guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks.

Advice on writing clear notices and maximising replies to your FSNs.

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

List of Field Safety Notices from 6 to 10 January 2025.

A programme to help facilitate robust decision-making across the entire lifecycle of products, benefitting both regulatory and Health Technology Assessment (HTA) evaluations relevant to the UK.

Progress made in delivering the Patient Involvement Strategy, October 2021 - January 2025.

Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed in this notification include an outdated PIL.

A programme to help facilitate robust decision-making across the entire lifecycle of products, benefitting both regulatory and Health Technology Assessment (HTA) evaluations relevant to the UK.

Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.

The ICH Expert Working Group for ICH M15 (EWG) has been drafting the ICH M15 MIDD guideline. The MHRA attended the EWG meetings and participated in the drafting group.

Bristol Laboratories Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the batches in the table for Rabeprazole sodium 10mg and 20mg gastro-resistant tablets do not contain the most up to date safety information.

UK approved bodies listed under?Medical Devices Regulations 2002?(SI 2002 No 618, as amended) (UK MDR 2002).

Parallel import licences granted in 2024

Marketing authorisations granted in 2024

Pharmacovigilance system requirements

The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)

UK companies who have their licence to manufacture or wholesale medicines terminated and cancelled.

Department of Health and Social Care and MHRA register of electronic export certificates (human).

Information about the EU Regulations and their implementation in Northern Ireland

List of Field Safety Notices from 30 December 2024 to 3 January 2025.

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

How the ‘Written Confirmation’ process operates for active substances manufactured in Great Britain (England, Wales and Scotland).

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