Guidance

Introducing new medicines in the NHS in the UK - pathway

Published 23 June 2025

The government wants NHS patients across the UK to be able to benefit from timely access to safe, clinically-effective and cost-effective new medicines. The regulatory and access pathways in place across the UK are designed to support this ambition, offering early advice on concurrent licensing and access.

In collaboration with system partners from across the UK health system, the Department of Health and Social Care has produced a pathway that is intended to support companies to navigate the medicines licensing and access pathway and signpost to more detailed information. This is not intended as a comprehensive guide but outlines:

• the routes to market
• how regulatory, health technology evaluation and commercial pathways align
• the mechanisms for company engagement including early advice services

Introduction

Several bodies and processes are involved in introducing a medicine into the NHS in the UK. The processes can take place in parallel to avoid unnecessary delays. The pathway can be divided into steps that begin before and after a company’s submission to the Medicines and Healthcare products Regulatory Agency (MHRA) for a marketing authorisation.

The processes that start before a company’s submission include:

• registering the product on UK PharmaScan - a database of information on potential new medicines and new indications used by horizon-scanning organisations
• the Innovative Licensing and Access Pathway (ILAP) - an optional process for new medicines that have not yet entered a confirmatory trial
• Early Access to Medicines Scheme - companies are able to apply for a positive opinion through the scheme if there are at least 6 months to marketing authorisation
• early advice and engagement from the MHRA, the National Institute for Health and Care Excellence (NICE) and other health system partners
• topic selection and scoping in preparation for a NICE health technology evaluation

To ensure as early market access as possible, companies should engage with NICE before submission to MHRA. This is because NICE health technology evaluation processes begin before MHRA regulatory processes. Companies should be thinking about health technology evaluation and pricing and commercial engagement, which lead to one of the following:

• managed access
• routine funding
• the ultra-orphan pathway (for Scotland)

The processes available for submission to the MHRA include:

• the national assessment procedure
• the Access Consortium work sharing initiative from MHRA
• Project Orbis - a programme to review and approve promising cancer medicines
• the international recognition procedure

Introducing medicines in the NHS in the UK - pathway

Figure 1: introducing medicines in the NHS in the UK - a visual pathway

The pathway is described below, and an interactive version of the pathway is available by emailing mbnicesponsorteam@dhsc.gov.uk.

UK PharmaScan

UK PharmaScan is a database of information on new medicines, indications and formulations in the pharmaceutical pipeline. Pharmaceutical companies enter data from 3 years before UK availability or the start of phase 3 clinical trials (whichever is earlier) up until availability in the UK.

Entering data into UK PharmaScan is an important step for companies as the information in UK PharmaScan informs horizon-scanning activities across the NHS in the UK, and supports efforts to ensure the system is ready to introduce new medicines in a timely manner.

NHS England, MHRA, NICE and horizon-scanning organisations use the data for:

• pathway and system planning
• identification of transformative medicines for the NHS Accelerated Access Collaborative
• development of health technology evaluation schedules by:
  • NICE
  • the Scottish Medicines Consortium (SMC)
  • the All Wales Medicines Strategy Group (AWMSG)
• production of briefings and resources for the NHS in England, Scotland and Wales
• local planning, such as formulary development, service design and budgeting
• informing national planning and prioritising engagement with companies

Innovative Licensing and Access Pathway

The Innovative Licensing and Access Pathway (ILAP) is an optional process for new medicines that have not yet entered a confirmatory trial. It is open to developers (both commercial and non-commercial) of potentially transformative medicines or drug-device combination products with a therapeutic aim where there is evidence of safe use in humans.

ILAP is a unique initiative which aims to accelerate the time it takes for transformative new medicines and drug-device combinations to reach patients. ILAP supports patient access by providing a single integrated platform for sustained collaborative working between the developer, the regulator, the UK health technology evaluation bodies, NHS England and devolved NHS partners, as well as patients.  

ILAP is the only end-to-end access pathway in the world where the developer can work collaboratively with the national health system, the regulator and health technology evaluation bodies. By engaging with medicine developers from the early stages of clinical development with tailored guidance and support, ILAP aims to facilitate accelerated access through better use of established regulatory and procedural services, facilitated by knowledge gained throughout development to enhance and align evidential requirements, including health system readiness.

ILAP is designed to: 

• provide a complementary pathway that gives developers co-ordinated and collaborative support to enable a system-wide approach for product development and access to the UK market
• apply to an identifiable cohort of potentially transformative technologies that address unmet clinical needs
• reduce the end-to-end timeline for product research and development, regulatory approval, health technology evaluation and the adoption of new technologies, which will benefit patients, health systems and the broader economy

Early Access to Medicines Scheme

The Early Access to Medicines Scheme (EAMS) is a UK-wide initiative that helps to give people with life-threatening or seriously debilitating conditions early access to new medicines that do not yet have a marketing authorisation but where there is a clear unmet medical need.

EAMS is an important part of the government’s commitment to accelerate patient access to innovative, life-changing treatments and support the UK’s position as a global leader in life sciences. EAMS can generate additional benefits for promising innovative medicines, including the potential to generate real-world evidence and build clinical experience of the new treatment.

Early access to medicines through the EAMS scheme is not funded and companies are required to provide the medicines free of charge. An application for EAMS can only be made where there is at least 6 months until the company expects to receive a marketing authorisation.

Once licensed, a product that has been available to NHS patients through EAMS will need to go through the established health technology evaluation process for a decision on routine funding.

Early advice and engagement

Advice and engagement - UK wide

MHRA conducts extensive data collection through their medicines pipeline data scheme and encourages companies to engage with them early through strategic meetings, particularly where there are innovative, transformative or disruptive technologies in the pipeline.

In addition, MHRA offers scientific advice at any point across the medicines lifecycle and particularly encourages organisations to request advice at the following points of the lifecycle:  

• first in human (FIH) studies
• design of pivotal clinical trials
• chemistry, manufacturing and control (CMC) and biological process requirements for marketing authorisation
• design of bioequivalence studies for generic medicines
• reclassification and repurposing programmes

MHRA has extensive experience and expertise to answer questions on the medicine lifecycle. Clear and specific questions submitted in advance of advice meetings are handled by the most relevant experts to deliver the advice.

Advice and engagement - England

NICE offers NICE Advice, a fee-based advisory service for pharmaceutical and health technology companies seeking to enter the NHS market. NICE Advice also supports organisations that fund or generate evidence for health tech.

The service provides scientific advice, strategic market access insights and education to help companies prepare for:

• a NICE evaluation
• engagement with NHS organisations, commissioners or the supply chain

By partnering with NICE Advice, companies can ensure their technologies meet NHS needs from the early stages of development, such as guiding them in collecting high-quality evidence that resonates with decision-makers. Engaging early in the planning process also means that feedback from system stakeholders across the UK can be built into a developer’s ongoing market access strategy. NICE Advice is a valuable resource for speeding up the NICE appraisal process and helping companies bring new treatments to NHS patients faster.

Advice and engagement - Scotland

The Scottish Medicines Consortium (SMC) offers early engagement meetings to discuss concerns or issues relating to SMC process or policy under specific circumstances, including when:

• there is a suggestion that the company may not be planning to make a submission and where there is exceptionally high patient need - for example, a medicine used for a condition where no other treatment is available
• a company has limited previous experience of engagement with SMC and/or aspects of the submission suggest there would be mutual benefit from a meeting

See the SMC website for more information on early engagement with companies.

Advice and engagement - Wales

The All Wales Therapeutics and Toxicology Centre (AWTTC) can offer advice on routes to access medicines in Wales, whether by a NICE submission or All Wales Medicines Strategy Group (AWMSG) assessment.

See the AWTTC website for more information on pharmaceutical industry submissions or you can email awttc@wales.nhs.uk.

Marketing authorisation

A UK-wide marketing authorisation is required before a medicine can be sold or supplied, or offered for sale or supply, in the UK. There are various regulatory routes to obtaining a marketing authorisation (MA) for a medicinal product in the UK.

See Apply for a licence to market a medicine in the UK for more information.

This section outlines the routes available to stakeholders, the pre-requisite requirements and statutory timelines.

Pre-submission notifications and requests

MHRA requires advance notice of MA applications at a minimum of 3 months before submission for any national:

• new active substance (NAS)
• biosimilar

Line extensions of any NAS should also be notified.

All applicants for these products should email presubmission@mhra.gov.uk providing information regarding the product, for example:

• international non-proprietary name (INN)
• indication
• route of administration
• intended application route
• intended date of submission

Where applicable, applicants will be asked to attend a pre-submission meeting.

See Pre-submission advice and support for further information.

National assessment procedure

The national assessment procedure is MHRA’s preferred regulatory pathway for innovative medicines. It provides a route to marketing authorisation and is open to all manufacturers and medicine types. MHRA makes a decision within 210 assessment days of receiving an application.

Conditional marketing authorisation

A conditional MA can be issued for medicinal products that fulfil an unmet medical need if comprehensive data is not available at the time of application but will become available. A conditional MA is valid for one year but is renewable. Examples would be for serious and life-threatening diseases where no satisfactory treatment methods are available or where the product offers a major therapeutic advantage.

The positive therapeutic effects of the product must be shown both to outweigh the risks to the health of patients and benefit public health by its immediate availability on the market. In short, the use of the medicinal product outweighs the risk inherent in the fact that additional data is still required.

Marketing authorisation under exceptional circumstances

Marketing authorisation under exceptional circumstances is available for medicines where a comprehensive data package cannot be provided because either of the following applies:

• the condition to be treated is rare
• collection of full information on safety and efficacy is not possible or is unethical

Approvals will only be granted under this provision where there are exceptional circumstances and where the applicant can demonstrate that it is not possible to provide comprehensive data on the efficacy and safety under normal conditions of use.

Access Consortium

Access Consortium offers a collaborative work-sharing licensing pathway that aims to promote timely patient access across the consortium while reducing duplication. The consortium is a partnership between the regulatory authorities of Australia, Canada, Switzerland, Singapore and the UK.

While this is a work-sharing initiative, each regulator retains the right to make individual decisions on the licensing of medicines under this scheme.

See more information under ‘Work sharing procedures’ of the Access Consortium guidance.

Project Orbis

Project Orbis provides near concurrent review and licensing of cancer medicines by international regulatory partners. Led by the US regulator, the Food and Drug Administration (FDA), Project Orbis aims to deliver faster patient access to innovative cancer treatments with potential benefits over existing therapies. Alongside the FDA, Project Orbis involves the regulatory authorities of:

• UK: MHRA
• Australia: the Therapeutic Goods Administration (TGA)
• Canada: Health Canada
• Singapore: the Health Sciences Authority (HSA)
• Switzerland: Swissmedic
• Brazil: Agência Nacional de Vigilância Sanitária (ANVISA)
• Israel: the Ministry of Health

Applications submitted to the MHRA within a Project Orbis procedure must be new marketing authorisation applications or new indication applications (variations) for cancer medicines.

There are 3 routes to MHRA under Project Orbis:

• A: submission within 30 days of FDA and concurrent review with FDA
• B: submission more than 30 days later than FDA
• C: submission of a product already approved by FDA

While MHRA welcomes all applications under Project Orbis, their preference is to run route A procedures, with concurrent assessment alongside FDA.

International recognition procedure

If a medicinal product has already been approved in Australia, Canada, the EU, Japan, Switzerland, Singapore or the US, it may be eligible for the international recognition procedure (IRP).

IRP allows MHRA to take into account the expertise and decision-making of trusted regulatory partners for the benefit of UK patients. MHRA will conduct a targeted assessment of IRP applications using the evaluation of the authorised product but retains the authority to make a national decision.

Health technology evaluation

A health technology evaluation assesses the costs and benefits of a technology to determine whether it represents a clinically-effective and cost-effective use of NHS resources.

Regulatory processes can run in parallel to health technology evaluation, minimising gaps between licensing and patient access. Each nation of the UK has its own arrangements for health technology evaluations.

NICE evaluation

NICE evaluates most new, licensed medicines and recommends whether they should be routinely funded by the NHS based on an assessment of their costs and benefits. NICE’s recommendations apply in England and are normally adopted by the NHS in Wales and Northern Ireland. A NICE evaluation is charged, see Costs: charging for technology appraisals and highly specialised technologies for further information.

Before the NICE evaluation starts, medicines go through a topic selection and scoping process to:

• determine the appropriate NICE process
• describe the patient population, intervention, comparators and outcomes relevant to the evaluation

A small proportion of medicines may not be evaluated by NICE where there is a clear rationale not to do so. See section 7.1.3 ‘Topics that involve use of new medicines’ in NICE-wide topic prioritisation: the manual for further information about the circumstances in which medicine may not be selected for a NICE evaluation. Such medicines may instead be considered for the development of an NHS England clinical commissioning policy, see further information from the Clinical Priorities Advisory Group (CPAG).

The NICE evaluation process usually requires the manufacturer to submit evidence that is evaluated by an independent appraisal committee. The timelines for the NICE evaluation process vary depending on the exact process. See Technology appraisal guidance for further information.

NICE also operates a separate highly specialised technologies programme for the evaluation of a small number of technologies for very small numbers of patients with very severe diseases. The highly specialised technologies programme operates a higher cost-effectiveness threshold. Decisions on whether a medicine is eligible for evaluation through the highly specialised technologies programme are taken by NICE against published criteria. See Highly specialised technologies guidance for further information.

All Wales Medicines Strategy Group evaluation

As NICE Technology appraisal guidance is mandatory within NHS Wales, the AWMSG takes account of the NICE work programme when considering whether to appraise a medicine. The AWMSG would not normally conduct an appraisal if NICE will appraise the medicine.

For medicines which are not assessed by NICE, or are not recommended by NICE, AWMSG has the option to appraise where there is a clearly identified clinical need or benefit to NHS in Wales in terms of service delivery. When AWMSG assesses a medicine through a health technology evaluation, the All Wales Therapeutics and Toxicology Centre (AWTTC) liaises with clinical experts, patients, carers and patient organisations, and the pharmaceutical industry to collect comprehensive evidence about the medicine.

The evidence on clinical and cost effectiveness is assessed AWMSG, along with the budget impact and wider societal factors and a recommendation is made on whether a medicine should be routinely available in NHS Wales. AWMSG recommendations are submitted to Welsh Government for ratification. Once ratified the recommendation is published and, if recommended for use or as an option for use, the medicine must be made available within NHS Wales where clinically appropriate within 60 days as a prerequisite of the New Treatment Fund. Any exceptions must be reported to the Chief Medical Officer for Wales.

The whole health technology evaluation process takes around 22 weeks to ensure that the medicine can be endorsed for NHS Wales as soon as possible after it is referred for assessment.

If NICE carries out and publishes health technology evaluation guidance for medicine that AWMSG has already assessed, NICE’s guidance will replace (supersede) AWMSG’s advice.

For pharmaceutical companies wishing to submit a medicine for AWMSG appraisal or to find out more about the health technology evaluation process, see the Submit for AWMSG appraisal page.

Scottish Medicines Consortium evaluation

In Scotland, SMC appraises the clinical effectiveness and cost effectiveness of newly licensed, prescription-only medicines. It provides advice on their routine use within NHS Scotland. SMC also reviews new indications of established medicines but does not review generic, branded generic, hybrid or biosimilar medicines nor unlicensed medicines or off-label uses of licensed medicines. SMC advice applies in Scotland only and there is no charge for an SMC evaluation.

Following a submission from the marketing authorisation holder, the New Drugs Committee (NDC) undertakes a technical assessment, which determines whether the evidence submitted is robust enough to recommend the medicine is accepted for use at that point or whether further assessment by the full SMC Committee is required. SMC also has an abbreviated process - see guidance on abbreviated submissions.

The SMC committee includes industry representatives and takes a range of factors into consideration when deciding whether to accept a new medicine under review. The committee considers the clinical and cost effectiveness evidence provided by the submitting company and other information, such as patient group submissions, to decide whether the medicine provides value for money. SMC can make one of the following 4 decisions on a medicine:

• accepted
• accepted with a restriction or restrictions - for example, the medicine can only be used in a particular group of patients with the condition. This typically occurs because the company has requested this explicitly in their submission
• accepted on an interim basis, subject to ongoing evaluation and reassessment
• not recommended

Decisions at SMC meetings are made by majority vote, and only full members have voting rights. Voting members include clinicians, NHS managers, academic health economists, public partners and Association of the British Pharmaceutical Industry (ABPI) members.

See How we make our decisions for further information.

Health boards in Scotland have procedures in place, under the peer approved clinical system (PACS) tier 2, for clinicians to apply on a ‘case by case’ basis for individual patients to request the use of a licensed medicine that is either not recommended for routine use in NHS Scotland or that has been submitted to and is awaiting or undergoing evaluation by SMC, where they consider there would be significant clinical benefit for that individual.

See Guidance on the implementation of the peer approved clinical system (PACS) tier 2 (PDF, 378KB) for further information.

Pricing and commercial engagement

A list price is required for all new branded medicines. Companies can submit a pricing application for a new branded medicine up to 12 months before marketing authorisation or a minimum of 28 calendar days before product launch. Following an assessment of the pricing application:

• prices will be formally agreed if marketing authorisation has been granted
• prices submitted before marketing authorisation will be assessed and informally agreed, with the prices formally confirmed once the marketing authorisation has been granted

Medicines undergoing NICE evaluation should have an NHS list price approved prior to a health technology evaluation.

A patient access scheme (PAS) is the starting point or default option for companies to consider when developing their value proposition for a health technology evaluation. It typically takes the form of a simple discount on the list price that is offered to the NHS. A PAS provides a mechanism for companies to improve the cost effectiveness of a treatment under evaluation beyond that driven by its list price. Unless treatment is to be considered by health technology evaluation bodies at the list price, companies should always include a PAS in their initial evidence submission to the health technology evaluation bodies to ensure sufficient time for full consideration in advance of the appraisal committee meeting.

During the health technology evaluation process, there are opportunities for commercial engagement between companies and the NHS to improve a product’s value proposition. While there are differences in health technology evaluation arrangements across the home countries, the expectation is that there will be equivalent pricing across the UK for equivalent access, in line with the commitment in the 2024 voluntary scheme for branded medicines pricing, access and growth (VPAG).

Commercial engagement - England

Unless a treatment is to be considered by NICE at list price, companies should always include a PAS in their initial evidence submission to NICE. The NICE Commercial Liaison team (CLT) advises NHS England on the feasibility of a PAS and makes the final decision on whether the proposed PAS can be considered as part of a NICE technology appraisal.

It is for NICE to determine whether the level of discount being offered by the company represents a clinically-effective and cost-effective use of NHS resources. There may be specific circumstances that make the launch of a product particularly challenging or commercially unviable on the basis of a PAS alone. NHS England may consider a confidential access agreement in these circumstances where the company proposes an enhanced value offer.

NHS England offers commercial surgeries to discuss the potential for commercial access or managed access agreements and clinical surgeries to discuss service implementation issues. These meetings are often most beneficial after the company submission but well in advance of the first NICE committee meeting, where the PAS has been approved and is considered to have been exhausted. This enables the commercial surgery to focus on specific commercial issues arising from the health technology evaluation submission, while providing enough lead time for companies to deliver on any solutions proposed during the surgery.

See the NHS England commercial framework for new medicines for further information.

Commercial engagement - Scotland

In Scotland, pharmaceutical companies can submit a PAS to improve the cost effectiveness of a medicine. A PAS can be proposed (or revised) at defined points of the SMC submission process. The Patient Access Scheme Assessment Group (PASAG) reviews and advises on the feasibility of proposed schemes for implementation. The group operates separately from SMC to maintain the integrity of the assessment process.

If no PAS is submitted assessment is based on list price.

See SMC guidance on Patient access schemes for further information.

Commercial engagement - Wales

In Wales, pharmaceutical companies should contact nhswales.ca@wales.nhs.uk for products undergoing an AWMSG evaluation.

For products undergoing NICE evaluation, NHS Wales will align commercial agreements with NHS England.

If a complex commercial agreement is being considered, pharmaceutical companies should contact the Medicines Value Unit (MVU) at nwssp.mvu@wales.nhs.uk for early engagement to support the implementation and adaptability of the commercial agreement within NHS Wales. 

Commercial engagement - Northern Ireland

In Northern Ireland, for products undergoing NICE evaluation, Health and Social Care Northern Ireland (HSCNI) will align commercial agreement with NHS England.

For early engagement to support implementation and adaptability of the commercial agreement within HSCNI, pharmaceutical companies should contact the Regional Pharmaceutical Procurement Service (RPhPS) at rphps.admin@northerntrust.hscni.net.

Managed access

Managed access only occurs in England and Wales.

Managed access agreements can give patients faster access to promising new treatments when they may otherwise not have been recommended because of uncertainties about their clinical or cost effectiveness. NICE is able to recommend the most promising medicines for a limited period of managed access, during which time additional evidence is collected. NICE will then use the additional information to assess whether the treatment should be made available for routine use on the NHS.

Medicines must demonstrate plausible potential cost effectiveness and be available for the entire population to enter managed access. The treatment is then available to patients in England through the Cancer Drugs Fund or Innovative Medicines Fund, each of which has an annual budget of £340 million, for a defined period of time while further real-world evidence is collected.

Medicines exiting the Cancer Drugs Fund or Innovative Medicines Fund are subject to a full NICE re-appraisal at the end of the managed access period, and a positive NICE recommendation is required to secure routine NHS funding. NICE takes the evidence generated through both funds into account in determining whether the treatment can be recommended for routine funding.

In Wales, the medicine licence holder is encouraged to share the details of a managed access agreement that has been agreed in England through the Medicines Value Unit (nwssp.mvu@wales.nhs.uk). Sometimes the licence holder may need to agree an alternative managed access agreement with NHS Wales, which offers equivalent value during the managed access period.

The terms of a managed access agreement between the NHS and the company will determine which patients may receive the medicine and for how long. The medicine may only be prescribed in specific circumstances, such as for patients with a condition meeting specific criteria for treatment. Recommendations with managed access are designed to allow gathering of further evidence about how well the medicine works.

Routine funding

Routine funding - England

NHS commissioners (NHS England or integrated care boards (ICBs)) are legally required to fund medicines recommended in a NICE technology appraisal or highly specialised technology evaluation, normally within 3 months of the publication of final guidance. There may be a few cases where the usual 3-month period for compliance with the statutory duty to fund a particular recommendation is extended, usually for a limited period, to allow the NHS to make arrangements for implementation. NHS organisations in England operate local formularies that list medicines that are approved for use in a specific location.

All NICE technology appraisal recommendations should - where clinically appropriate - be automatically incorporated into local formularies. This process should normally take place within 90 days to support compliance with the funding requirement ensuring that these medicines are available for clinicians to prescribe, should they choose to, in a way that supports safe and clinically appropriate practice.

Routine funding - Wales

Medicines are funded in NHS Wales when recommended for use by AWMSG and ratified by the Welsh Government or when recommended for use by NICE.

Health boards in Wales are expected to add medicines to their local formularies and make medicines available to patients within 60 days following the publication of the Welsh government-supported AWMSG guidance or NICE final draft guidance.

See How medicines are approved for use in NHS Wales for further information.

Routine funding - Scotland

Area Drugs and Therapeutic Committees within each of Scotland’s 14 NHS health boards have 90 days from the publication of advice from SMC to consider whether to make the medicine or an equivalent available from their formulary.

Routine funding - Northern Ireland

Where NICE guidance is found to be applicable by the Department of Health, it is endorsed for implementation within HSCNI. In practice, this means that treatments that NICE has recommended for routine use in the NHS in England are also routinely available in Northern Ireland through the Northern Ireland Formulary Managed Entry process.

Ultra-orphan pathway (Scotland)

The ultra-orphan pathway has been established to ensure those with the rarest of diseases will get access to new and innovative medicines by allowing eligible medicines to be made available through NHS Scotland for a period of 3 years prior to a decision on routine use being made.

The current definition of ultra-orphan medicine applies to very rare conditions. To be considered as an ultra-orphan medicine, all criteria listed should be met:

• the condition (typically a recognised distinct disease or syndrome) has a prevalence of 1 in 50,000 - around 100 people - or less in Scotland
• the medicine has a Great Britain (GB) orphan marketing authorisation from the MHRA
• the condition is chronic and severely disabling
• the condition requires highly specialised management

Submissions for medicines that are validated as ultra-orphan will be assessed by SMC and will then be available to prescribers for a period of up to 3 years while further clinical-effectiveness data is gathered.

Companies are expected to submit a short report outlining their evidence generation and data collection plans for the 3-year data collation period to the Scottish Government. See Ultra-orphan medicines pathway: guidance for further information on the evidence generation phase.

After the agreed period, the company will be asked to provide an updated submission for reassessment, and SMC will make a decision on the routine use of the medicine in NHS Scotland.

See SMC guidance on Ultra-orphan medicines for extremely rare conditions for further information.