The ILAP provides developers with access to a single integrated platform for sustained working between the developer, the regulator, the UK Health Technology Assessment (HTA) bodies and the National Health Service (NHS).   

Products that enter the ILAP will benefit from joined-up, system-wide guidance and support from the early stages of clinical development. It will facilitate a life-cycle approach for product development by harnessing the power of collaboration between the MHRA, NHS, HTA bodies and patients to reduce the time to patient access for transformative medicines. 

This section details the specific services available to support developers in the ILAP. It includes core services which all innovation passport holders will have access to. This includes the Target Development Profile (TDP), as well as optional support that may be recommended to help maximise opportunities for accelerating a product’s journey through clinical development, access and uptake.  

Services exclusively offered in the ILAP include the ILAP Joint Scientific Advice (JSA) and the ILAP Access Forum, as well as operational planning and system preparedness support for the introduction of medicines into standard patient care. Innovation Passport holders receive prioritised scheduling to gain access, at the right time, to a range of services offered by the ILAP partners, such as the Medicines and Healthcare products Regulatory Agency (MHRA) scientific advice, MHRA Pre-submission meetings and the National Institute for Health and Care Excellence (NICE) Advice services. 

It is expected that additional services will be added to further enhance the offer as the ILAP progresses. 

For all Innovation Passport holders 

Target Development Profile (TDP) 

At the point of confirmation on entry onto the ILAP, developers will be offered a meeting with the ILAP partners to develop a TDP. The TDP is accessible following confirmation of the Innovation Passport. Developers must commit to collaborating with the ILAP partners to create a TDP within 6 months after receiving the Innovation Passport. 

This will enable developers to meet with a team consisting of all the ILAP partners, to define the TDP based on the product’s development needs.   

The TDP establishes a collaborative platform for the ILAP partners to review a product’s development, aiming to streamline, align and coordinate evidence generation and evaluation, whilst identifying key implementation and service delivery issues. The TDP will outline a product’s critical regulatory and developmental aspects, identifying potential challenges, and providing a roadmap for delivering early access for patients.  

It is expected that the TDP roadmap is a living document, updated along the development programme timelines and milestones as new knowledge is generated. 

The TDP roadmap provides a pathway for facilitating a regulatory and access ready approach to medicines development. It will indicate which ILAP services are considered important for the advancement of the product through to regulatory approval and patient access and identify key areas for future engagement. 

Regular Interactions  

The Innovation Passport holder will be appointed a dedicated point of contact to coordinate all support provided through the ILAP and can support with access to the various services on offer.  

Fees: Target Development Profile (TDP)

Initial Target Development Profile (TDP) fee: £4,451 

Please note that the MHRA updates its fees on a regular basis. Changes to the MHRA’s fees will be implemented in April 2025 and therefore fees quoted may be subject to change.    

The ILAP Services 

The ILAP services can be accessed by Innovation Passport holders after receiving a TDP. The services are intended to drive efficiencies in the product’s development programme, supporting data generation, evidence requirements and market access.  

The ILAP will undergo an interactive and iterative process of improvement with more services added in the future.  

Developers will receive information on how to access these services after receiving their TDP. 

Prioritised Access to Key Services  

Exclusive to the ILAP 

Entry into the ILAP grants Innovation Passport holders access to ILAP specific services. These enable interactions between Innovation Passport holders and all relevant ILAP partners and patients as part of the unique system wide approach at key points in the product lifecycle. These are: 

• The ILAP Joint Scientific Advice (JSA) 
• The ILAP Access Forum  

Priority Scheduling Pass 

Entry into the ILAP grants Innovation Passport holders a Priority Scheduling Pass. This enables products with an Innovation Passport to be prioritised in the ILAP partners work schedule. Priority scheduling enables timely interactions between Innovation Passport holders and the ILAP partners, supporting efficient product development by delivering essential services at optimal points in the product lifecycle, precisely when they are most needed. The scheduling pass is complemented by the TDP, which recommends use of specific services at critical points, along the product’s development path. 

The following services benefit from the priority scheduling pass: 

• MHRA Scientific Advice   
• MHRA pre-submission meetings  
• Clinical Practice Research Datalink (CPRD)  
• NICE Advice services for example the health economic model advice service (excluding NICE technology appraisal/Highly Specialised Technologies evaluation) 
• At Scottish Medicines Consortium (SMC), prioritisation for evaluation and potential eligibility for interim acceptance 
• National Institute for Health and Care Research (NIHR) Study Support Service  

Fees: Prioritised Access to Key Services   

Standard fees apply. There are no extra costs associated with priority scheduling. 

Clinical development 

The ILAP offers a range of services designed to streamline and accelerate the products progress during the clinical development stages. This will support developers to generate the required evidence in the most efficient way, for the provision of adequate data for benefit–risk assessment at the time of Marketing Authorisation Application (MAA) and Health Technology Assessment (HTA). 

The ILAP Joint Scientific Advice  

The ILAP Joint Scientific Advice service is only available for products on the ILAP and is designed to provide advice on the evidence generation plans for a product from a regulatory and HTA perspective.  

The service is delivered by NICE in partnership with AWTTC, the MHRA and the SMC. 

How it can help 

Having a joint discussion with the MHRA and HTA agencies will help develop a more efficient and relevant evidence generation strategy, which could potentially reduce delays and barriers in the product development, regulatory assessment and market access journeys. 

The ILAP Joint Scientific Advice can be used to provide advice in the following areas: 

• Prospective clinical trial/clinical investigation and novel trial design plans, including advice on study population and subgroups, comparators, endpoints, and patient reported outcomes. 
• Real world evidence generation plans, including use of relevant patient registries for data collection. 
• Health economic plans, including advice on economic modelling approach and relevant data input. 

The ILAP Joint Scientific Advice cannot be used to: 

• design trial protocols or economic models, 
• endorse proposals, 
• discuss how to price a product, or 
• provide an early evaluation of the product 

How it works 

The developer creates a briefing book with key questions and shares their draft protocols and evidence with us, and we set up and facilitate the advice meeting. The advice meeting is a confidential meeting for up to 3 hours, usually delivered virtually. It includes company representatives, ILAP partner representatives (MHRA, NICE, SMC, AWTTC), and external experts, which may include clinicians, patients, HTA and academic experts as appropriate. The developer will also receive two comprehensive advice reports detailing the discussion and recommended actions. 

The developer will benefit from signed confidentiality agreements, sharing of relevant declarations of interests for those involved, and assurance that the advice provided is non-binding on any party. 

This service is not part of formal HTA guidance processes, although it will help prepare for the regulatory and HTA evaluations. 

Read more information on NICE Advice service. 

Fees: Clinical development 

A fee estimate range can be provided during the TDP meeting; however, as a bespoke service, exact pricing will be determined by the specific needs of the developer.  

Clinical Trial Delivery 

Innovation Passport holders will, via the NIHR Research Delivery Network (RDN), have access to England’s national research delivery infrastructure, reducing the time and effort needed to plan, place, set-up and deliver clinical trials. Through the RDN, companies can access opportunities for delivering studies across the breadth of England. The RDN currently supports studies in every NHS Trust in England and approximately 56% of GP practices, as well as organisations in other community and residential settings. 

NIHR Study Support Service 

Innovation Passport holders get ready access to the support on offer through the NIHR Study Support Service, providing access across the RDN to: 

• Support study-wide planning activities such as identifying extra trial sites including Patient Identification Centres (PICs) and the new Site Scoping Tool. 
• Clinical advice, such as assessment of study deliverability in the UK, recommendations of recruitment methods and pathways, study design considerations. 
• Research delivery advice - advising on the most efficient recruitment strategies and recruitment settings you may not have considered in the original protocol. This includes setting-specific delivery advice, regional care pathways, NHS support services, investigators, capabilities and exploring digital recruitment methods. 
• Opportunity to discuss site or trial delivery issues affecting study delivery, with support to overcome barriers or delivery challenges 

This also provides access to the Sponsor Engagement Tool, to provide a more efficient and effective way for sponsors to provide regular assessments of study progress and ensure the data that the Network holds is up-to-date. This will result in improved data quality and accuracy which can be used to improve study planning and placement to make best use of the research system’s capacity and capability. 

Fees: Clinical Trial Delivery  

There are no fees for this service. 

Active National Delivery 

Innovation Passport holders who are seeking to undertake commercial clinical trials in the UK will have access to the new Active National Delivery Service offered by the NIHR RDN when it is launched later in 2025.  

Sponsors will benefit from bespoke services, including: 

• Enhanced centralised support and easy access to the flexible resource provided by the NIHR RDN Agile Research Delivery Team, who are staff based in Regional Research Delivery Networks (RRDNs) across England. They are skilled, multi-disciplinary teams who can work flexibly across a variety of different locations to support research delivery.  
• Access to the NIHR Patient Engagement in Clinical Development Service to help you ensure your clinical trials are participant-friendly, enabling direct engagement with patients, members of the public, and carers to improve the design and delivery of your research. This also helps meet growing regulatory requirements and industry-wide codes of conduct, while working within your internal company guidelines. 
• The RDN will also be able to link you into the Commercial Research Delivery Centres (CRDCs) across the UK, which are bespoke facilities to deliver later phase trials for the for the life sciences industry.  

Innovation Passport holders will be able to access support and advice from the NIHR RDN to guide holders through study development and delivery to meet the evidential requirements for transit through regulatory and HTA processes. The nature and extent of this support will be further explored as part of the piloting of Active National Delivery. 

Further details on the Active National Delivery service, including the full range of options that will be made available through the future service, will be published later in 2025. 

Fees: Active National Delivery 

This service will be on offer for commercial clinical trials on a fee-for service basis. As a bespoke service, exact pricing will be determined by the specific needs. 

Clinical Practice Research Datalink  

Products in the ILAP will get prioritised access to services from the Clinical Practice Research Datalink (CPRD), which is the pre-eminent UK real-world research service supporting retrospective and prospective public health studies and interventional research. CPRD collects pseudonymised patient data from a network of General Practices across the UK. This primary care data is linked to a range of other health-related data to provide an anonymous, longitudinal, representative UK population health dataset. 

How it can help 

CPRD can improve the efficiency of clinical studies delivery through innovative data-driven approaches and offers a range of data and services to support developers throughout the product development lifecycle. This includes access to: 

• High quality longitudinal data on 60 million patients, many with over 20 years of follow-up 
• A potential pool of over 18 million currently registered patients, enabling speedy recruitment into phase 3 clinical trials through the CPRD SPRINT (Speedy Patient Recruitment INto Trials) service, which is tailored to support organisations rapidly recruit patients, through near real-time centralised searches of UK-wide electronic health records. 
• Research services based on real world data which can be used to support regulatory and Health Technology Assessment submissions, including: 
• Providing a longitudinal and representative UK perspective of the current epidemiological landscape for patient cohorts 
• Delivering external control arms for both single- and multi-arm trials, using retrospectively and/or prospectively collected data to assess the internal and/or external validity and provide context to trial results. 
• Post authorisation safety, efficacy and utilisation data and services due to the high-quality data collected on primary and secondary care resource utilisation, and clinical outcomes of efficacy and safety in the real world. 

Find out more about CPRD 

Fees: CPRD

Find out more about CPRD fees. 

Market Access 

The ILAP offers a range of services designed to streamline and accelerate the product’s progress during the licensing and HTA stages. It supports developers to determine the most appropriate licensing route and information needed to enable first-right-time applications, as well as maximising opportunities to benefit from time saved through parallel assessments between the MHRA and the NICE.  

The ILAP Access Forum  

The ILAP Access Forum is an exclusive offer to the Innovation Passport holders and aims to promote understanding of the market access approaches that will optimise the route to patient access. 

Unpacking market access challenges and addressing these upfront through early engagement with system stakeholders from England, Scotland and Wales is a key enabler for achieving timely patient access. 

This service, which is delivered by NICE in partnership with the AWTTC, SMC, and NHS England (NHSE) aims to provide a joined-up view from system stakeholders in the UK on themes such as: 

• Where the new technology may potentially fit in the care pathway in order to contextualise the value proposition. This is particularly important in situations where the current care pathway is complex or undefined, or in situations where the clinical trial was not conducted in the UK. 
• Service delivery implications of introducing the technology into the NHS, including any commissioning considerations, testing requirements, infrastructural changes, and other implementation activities necessary to facilitate the use of the technology once it receives a positive reimbursement decision. 
• High level HTA challenges. This could include helping developers to navigate the different HTA routes for each nation where applicable and understanding the implications of the processes and methods for the technology. It is also an opportunity to understand how to best engage with the HTA agencies and to optimise a HTA submission strategy. (In-depth technical questions on evidence generation should be addressed via the Joint Scientific Advice service). 
• Clarification on how different life sciences initiatives/ processes will apply in practice. As the healthcare landscape continues to evolve rapidly, it can be difficult to navigate current and new processes / initiatives and what these could mean for a developer’s technology in practice. 
• How commercial processes are likely to apply.  

How it can help 

Engaging early in the planning process means that feedback from system stakeholders across the UK can be built into a developer’s ongoing market access strategy. Acting on this feedback will help to develop the right approaches to optimise the route to patient access. 

This service is particularly useful for products that need careful management into the system. It is most suitable for products that may involve complex HTA and commercial challenges, radical changes to an established care pathway, and significant changes to service delivery, infrastructure, training and workforce. The service is not a mechanism for making HTA routing decisions, challenging existing decisions made by the HTA guidance programmes or challenging national policies.  

How it works 

Market access challenges are systematically ‘unpacked’ through preparatory discussions to understand the developers needs and the market access insights they are looking for. 

We develop the scope of the meeting and work with the developer to finalise the structure, content and attendance. 

AWTTC, NHSE NICE and SMC identify and bring together the most appropriate people in the healthcare systems in England, Scotland and Wales for developers to engage with to gain insight for ongoing market access planning. This may include stakeholders such as clinical, patient groups, HTA, and NHS experts where appropriate. 

Engagement meetings are facilitated and conducted in a safe harbour environment. This ensures confidential, free-flowing, peer-to-peer discussions, which can act as the basis for ongoing engagement with system stakeholders. 

Developers’ will benefit from signed confidentiality agreements (for people not already covered by their system contracts), sharing of relevant declarations of interests for those involved, and assurance that discussions are non-attributable, non-binding and non-transmissible. 

This service is not part of formal HTA guidance processes. It provides expert feedback to support development of the optimal market access approach. 

Read more information on NICE Advice service. 

Fees: Market access

 A fee estimate range can be provided during the TDP meeting; however, as a bespoke service, exact pricing will be determined by the specific needs. 

Health System Adoption 

The ILAP will offer a range of support to engage with NHS partners (including NHSE and parties representing NHS organisations in Scotland and Wales) from the early stages of clinical development to inform operational planning and system preparedness for the potential introduction of medicines into standard patient care across the UK.  

NHS partners will provide a range of services based on an underlying assumption that products with an Innovation Passport will achieve a market authorisation and have a reasonable potential to achieve a subsequent positive HTA determination. This will include: 

• Providing advice and guidance to understand the available routes to NHS access. 
• Facilitating engagement with appropriate clinical and commissioning expertise to identify any potential barriers to future adoption and uptake. 
• Supporting the development of a UK-wide adoption strategy.  
• Monitoring and evaluating the uptake of ILAP products across the NHS to understand variation in adoption.  

Further details on the services available to support health system adoption, including the full scope of the adoption strategy that will be made available, will be published later in 2025. 

Fees: Health System Adoption 

There are no fees for this service.