# Introducing new medicines in the NHS in the UK

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/ea9efc8f-9ebf-4486-a6e0-1c440cf56029
Type: Guidance
Published: June 23, 2025

> This regulatory framework outlines the access pathway for pharmaceutical companies introducing new medicines to the NHS in the United Kingdom. Although the guidance does not cite specific companies, inspection dates, or violations typical of enforcement reports, it establishes a rigorous process for market entry. The framework requires companies to notify the health system of new products using the UK Pharmascan platform and to engage with available advisory services. The regulatory process integrates marketing authorization with health technology evaluation to ensure clinical and economic suitability. Required actions for manufacturers include early notification and adherence to the defined evaluation milestones. The pathway excludes clinical trial phases and the subsequent use of medicines within the NHS after evaluation. Primarily aimed at pharmaceutical firms, patient organizations, and clinicians, the document emphasizes that the pathway is subject to ongoing review to accommodate changes in the UK regulatory landscape. Stakeholders must remain compliant with these evolving standards to ensure successful product launches and patient access within the UK healthcare system.

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## Content

The pathway covers the regulatory and access route for companies wishing to introduce new medicines to the NHS. The process includes: companies notifying the health and care system of their products through UK Pharmascan the advisory services that are available to companies marketing authorisation and health technology evaluation processes The pathway does not include clinical trial stages or the NHS use of medicines after health technology evaluation. The primary audience for the pathway is expected to be pharmaceutical companies preparing to launch their products in the UK, but it will also be of value to other stakeholders, such as patient organisations and clinicians. The pathway will be kept under review on an ongoing basis to reflect changes to the regulatory and access pathways.

## Attachments

- [Introducing new medicines in the NHS in the UK - pathway](/government/publications/introducing-new-medicines-in-the-nhs-in-the-uk/introducing-new-medicines-in-the-nhs-in-the-uk-pathway)