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Medicines, medical devices

Guidance and regulation

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  • Report on the service providing sterile, controlled environments for the preparation of injectable medicines into ready-to-administer formats for patients.

  • Guidance for manufacturers on reporting adverse incidents involving breast implants under the vigilance system.

  • Guidance for hospital blood banks on issuing blood components electronically in line with best practice.

  • Sets out opportunities for commissioners and providers to realise community pharmacy’s role in protecting and improving the nation's health.

  • Guidance and specifications for the recording and extraction of CTAD data from laboratories in England processing LA and NHS commissioned chlamydia tests.

  • Information on how the ACBS factors in the issue of pricing, when reviewing product applications.

  • Provide innovators and developers of innovative products access to MHRA scientific expertise, regulatory guidance and an enhanced advice and signposting service.

  • A summary of actions related to problems with T34 syringe drivers

  • Advice and guidance on the management and use of point-of-care testing (POCT) in vitro diagnostic (IVD) devices.

  • AI Airlock programme develops industry and regulatory expert collaboration, bespoke testing plans, and improved regulatory understanding.

  • An overview of the five technologies selected for the AI Airlock pilot.

  • Information for patients, healthcare professionals and the wider public to help better understand the importance of AAIs as a potential life-saving medicine.

  • Guidance for local partnerships on how to review adult drug and alcohol related deaths and near-fatal overdoses to prevent future deaths.

  • Information for pharmaceutical wholesalers explaining the main changes the Windsor Framework introduces to the packaging for all medicines licensed in the UK, effective from 1 January 2025.

  • Outcomes from the first meeting with the regulators of medicine who had met globally to discuss dementia.

  • A series of webinars providing guidance on the Windsor Framework agreement and the supply of medicines in Northern Ireland.

  • Sets out the payment due from members of the voluntary scheme for branded medicines pricing and access in 2022.

  • Helping interpret the Human Medicines (Amendment) Modular Manufacture and Point of Care regulations 2025 regulations.

  • How equipment for temperature screening is regulated, the limitations of temperature screening for detecting COVID-19 and advice on buying and using these products.

  • Information and advice on submitting a dermatological product to the Advisory Committee for Borderline Substances (ACBS).