NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

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UNITED KINGDOM
Medicines and Healthcare products Regulatory Agency (MHRA)

MHRA Business Plan 2024/25

On 7th October 2024 the MHRA published its new business plan for 2024/25, setting out the agency’s core focus of enabling access to innovative healthcare products while ensuring delivery for all who need its services – patients and the public, healthcare professionals, researchers and developers.

Statutory Instrument laid in Parliament provides first regulatory framework of its kind for the manufacture of innovative medicines at the point of patient care

A draft Statutory instrument was laid in Parliament on 21st October. The legislation aims to transform the manufacture of innovative medicines at the point of care. The UK will be the first country globally to introduce a tailored framework for the regulation of innovative products manufactured at or close to the location where a patient receives care. This new legislation will:

Allow medicines with a very short shelf life and highly personalised medicines to be manufactured in or near a hospital setting so that patients can access them more effectively
Allow manufacture of innovative medicines in small, portable units that can be set up close to patients who may be unable to travel or where rapid medicine availability is best served.
Help relieve pressures on hospitals by enabling delivery of care where it is most appropriate for the patient,
Enable the safe development of innovative, personalised products such as cell or gene therapy that need to be manufactured close to the individual patient.
The legislation proposes a six-month implementation period once Parliamentary processes have been concluded. This regulation could, therefore, become law in Summer 2025.

Statutory Instrument laid in Parliament sets out first steps in delivering Medical Device Regulatory Reform and strengthening patient safety

The Post-market Surveillance (PMS) Statutory instrument laid in Parliament on 21st October 2024 is the first major update to the framework of medical device regulations in Great Britain. Please find the draft statutory instrument, explanatory memorandum and impact assessment here. A summary of the key changes to the regulation is available here.

Health Research Authority (HRA)

HRA and MHRA draft inclusion and diversity guidance

The Health Research Authority (HRA) have launched an informal consultation on a draft guidance being produced with the MHRA which aims to help increase the inclusion and diversity of people taking part in clinical trials and clinical investigations. The deadline for comments is 9th December 2024.

National Health Service (NHS) England

National contract value review; advanced therapeutic medical products (ATMPs) will be incorporated

From October 2024, as part of work to accelerate commercial research setup in the UK, the National Contract Value Review (NCVR) will incorporate clinical trials of ATMPs. The NCVR is a standardised, national approach to costing for commercial contract research. To support this change, a new model clinical trial agreement for ATMPs and a new clinical research organisation (CRO) model clinical trial agreement for ATMPs are introduced. The new templates have been developed by the Four Nations Contracts Leads, which consists of representatives from the HRA and the Devolved Administrations of Northern Ireland, Scotland and Wales. With this, ATMP clinical trials now have new pre-agreed template agreements, which should be used without modification for all phases of ATMP clinical trials. — https://ct.catapult.org.uk/news/regulatory-round-up-october-2024