Pathway for Introducing New Medicines in the UK NHS

1. Publication Details

Published 23 June 2025. This publication is licensed under the Open Government Licence v3.0. https://www.gov.uk/government/publications/introducing-new-medicines-in-the-nhs-in-the-uk/introducing-new-medicines-in-the-nhs-in-the-uk-pathway

2. Introduction

The government aims for NHS patients across the UK to benefit from timely access to safe, clinically-effective, and cost-effective new medicines. Regulatory and access pathways support this by offering early advice on concurrent licensing and access. In collaboration with UK health system partners, the Department of Health and Social Care produced a pathway to help companies navigate licensing and access, outlining routes to market, alignment of regulatory, health technology evaluation, and commercial pathways, and mechanisms for company engagement including early advice services. https://www.gov.uk/government/publications/introducing-new-medicines-in-the-nhs-in-the-uk/introducing-new-medicines-in-the-nhs-in-the-uk-pathway Several bodies and processes are involved in introducing a medicine into the NHS. Processes can run in parallel to avoid delays. The pathway divides into steps before and after a company’s submission to the Medicines and Healthcare products Regulatory Agency (MHRA) for marketing authorisation. Pre-submission processes include: registering on UK PharmaScan, the Innovative Licensing and Access Pathway (ILAP), Early Access to Medicines Scheme, early advice from MHRA, NICE, and others, and topic selection for NICE health technology evaluation. Companies should engage NICE before MHRA submission as evaluation begins earlier, considering health technology evaluation and pricing leading to managed access, routine funding, or ultra-orphan pathway (Scotland). MHRA submission processes include national assessment, Access Consortium, Project Orbis, and international recognition procedure. https://www.gov.uk/government/publications/introducing-new-medicines-in-the-nhs-in-the-uk/introducing-new-medicines-in-the-nhs-in-the-uk-pathway

3. UK PharmaScan

UK PharmaScan is a database for new medicines, indications, and formulations in the pharmaceutical pipeline. Companies enter data from 3 years before UK availability or phase 3 trials start. It informs horizon-scanning across the UK NHS, supporting planning, identification of transformative medicines for NHS Accelerated Access Collaborative, health technology evaluation schedules by NICE, SMC, AWMSG, production of briefings for NHS in England, Scotland, Wales, local planning like formulary development, and national prioritising. https://www.gov.uk/government/publications/introducing-new-medicines-in-the-nhs-in-the-uk/introducing-new-medicines-in-the-nhs-in-the-uk-pathway

4. Innovative Licensing and Access Pathway (ILAP)

ILAP is optional for new medicines not yet in confirmatory trials, open to developers of transformative medicines or drug-device combinations with safe human use evidence. It supports patient access via collaborative platform between developer, regulator, health technology bodies, NHS England, and partners including patients. ILAP aims to accelerate access through regulatory services, aligning evidential requirements. Designed to provide coordinated support for system-wide approach, apply to transformative technologies addressing unmet needs, reduce end-to-end timeline for development, approval, evaluation, and adoption benefiting patients and economy. https://www.gov.uk/government/publications/introducing-new-medicines-in-the-nhs-in-the-uk/introducing-new-medicines-in-the-nhs-in-the-uk-pathway

5. Early Access to Medicines Scheme (EAMS)

EAMS is UK-wide for giving early access to new medicines without authorisation for life-threatening or debilitating conditions with unmet need. Part of commitment to accelerate innovative treatments, generating real-world evidence. Medicines provided free by companies. Application requires at least 6 months to authorisation. After licensing, goes through health technology evaluation for routine funding. https://www.gov.uk/government/publications/introducing-new-medicines-in-the-nhs-in-the-uk/introducing-new-medicines-in-the-nhs-in-the-uk-pathway

6. Early Advice and Engagement

6.1 UK-Wide

MHRA collects data via medicines pipeline scheme, encourages early strategic meetings for innovative technologies. Offers scientific advice across lifecycle, especially for FIH studies, pivotal trials, CMC requirements, bioequivalence for generics, reclassification. Handles clear questions by relevant experts. https://www.gov.uk/government/publications/introducing-new-medicines-in-the-nhs-in-the-uk/introducing-new-medicines-in-the-nhs-in-the-uk-pathway

6.2 England

NICE offers NICE Advice, fee-based for pharmaceutical and health tech companies entering NHS. Provides scientific advice, market access insights, education for NICE evaluation or NHS engagement. Helps collect high-quality evidence, integrate feedback early, speed appraisal process. https://www.gov.uk/government/publications/introducing-new-medicines-in-the-nhs-in-the-uk/introducing-new-medicines-in-the-nhs-in-the-uk-pathway

6.3 Scotland

SMC offers early engagement for concerns on process/policy, e.g., no planned submission with high patient need, or limited experience. More info on SMC website. https://www.gov.uk/government/publications/introducing-new-medicines-in-the-nhs-in-the-uk/introducing-new-medicines-in-the-nhs-in-the-uk-pathway

6.4 Wales

AWTTC offers advice on access routes in Wales via NICE or AWMSG. More info on AWTTC website or email. https://www.gov.uk/government/publications/introducing-new-medicines-in-the-nhs-in-the-uk/introducing-new-medicines-in-the-nhs-in-the-uk-pathway

7. Marketing Authorisation

UK-wide authorisation required before sale/supply. Various routes: https://www.gov.uk/government/publications/introducing-new-medicines-in-the-nhs-in-the-uk/introducing-new-medicines-in-the-nhs-in-the-uk-pathway

7.1 Pre-Submission Notifications

MHRA requires 3-month notice for national NAS, biosimilar, line extensions. Email with product details. Pre-submission meeting may be required. https://www.gov.uk/government/publications/introducing-new-medicines-in-the-nhs-in-the-uk/introducing-new-medicines-in-the-nhs-in-the-uk-pathway

7.2 National Assessment Procedure

Preferred for innovative medicines, open to all. Decision within 210 days. https://www.gov.uk/government/publications/introducing-new-medicines-in-the-nhs-in-the-uk/introducing-new-medicines-in-the-nhs-in-the-uk-pathway

7.3 Conditional Marketing Authorisation

For unmet needs with future data. Valid 1 year, renewable. Benefits outweigh risks. https://www.gov.uk/government/publications/introducing-new-medicines-in-the-nhs-in-the-uk/introducing-new-medicines-in-the-nhs-in-the-uk-pathway

7.4 Exceptional Circumstances

For rare conditions or impossible full data. Granted where comprehensive data not possible. https://www.gov.uk/government/publications/introducing-new-medicines-in-the-nhs-in-the-uk/introducing-new-medicines-in-the-nhs-in-the-uk-pathway

7.5 Access Consortium

Collaborative with Australia, Canada, Switzerland, Singapore, UK. Each regulator decides independently. https://www.gov.uk/government/publications/introducing-new-medicines-in-the-nhs-in-the-uk/introducing-new-medicines-in-the-nhs-in-the-uk-pathway

7.6 Project Orbis

Concurrent review for cancer medicines with FDA lead, involving UK, Australia, etc. Aims faster access. https://www.gov.uk/government/publications/introducing-new-medicines-in-the-nhs-in-the-uk/introducing-new-medicines-in-the-nhs-in-the-uk-pathway