The Innovative Licencing and Access Pathway (ILAP) launched on the 1st of January 2021, a flagship Agency service offered by the Medicines and Healthcare products Regulatory Agency (MHRA). This platform was created to accelerate the time to the UK market for innovative medicines, here is how:
The Innovation Passport
The Innovation Passport Designation is the mandated entry point to ILAP, and the entrance criteria are broad and flexible. During the first year of operation, the MHRA received 71 applications and awarded 41 innovation passports.
The unique feature about ILAP is that it connects the functions of the MHRA, the National Institute for Health and Care Excellence (NICE), NHS England, the Scottish Medicines Consortium (SMC), and The All Wales Therapeutics and Toxicology Centre. Together with contributing patient representatives, all the stakeholders are jointly granting the Innovation Passport designation, setting the stage right from the beginning.
The Innovation Passport is open to developers already at the pre-clinical stage. Ideally, organisations should apply to the pathway as early as possible. This way, the ILAP partners can provide you with more accurate advice on clinical trial design and data generation to meet the needs of both regulatory and reimbursement assessment.
To qualify, the applicants must demonstrate that the indication has the potential to offer significant benefits to patients with a life-threatening or seriously debilitating condition or meet a significant public health need.
Examples of high priority indications:
- New vaccines
- Advanced therapy products such as cell and gene therapies
- Biologic or chemical treatments
- Novel drug-device combinations
- Repurposed medicines
- Medicines for rare diseases
The number of applications for Innovation Passport Designation highlights considerable interest from the pharmaceutical industry, many of them in the oncology area. Moving forward, the MHRA and NICE have exploratory work underway to evaluate medical devices under the ILAP process to offer key support in their development plan in the future.
The Target Development Profile
Once successful innovation passport designation has been achieved, the development of a Target Development Profile (TDP) is initiated. The TDP is a tailored roadmap for the product’s development and should define how best to address both regulatory and market access considerations and identify potential pitfalls.
The first step is to submit a TDP form, gathering relevant information on the product development, such as an evidence generation plan, scientific advice, and patient engagement. After submitting the TDP form, the sponsor, the MHRA and partners meet and discuss the prerequisites of the TDP roadmap best suited for the development of the product.
The TDP is continuously updated along with the development programme timelines and milestones as new knowledge is collated. Sections in the TDP covers a wide range of support including scientific advice, patient engagement and product life cycle.
The TDP Toolkit
The TDP is supported by a set of tools that include different activities designed to keep the evidence generation on track. The TDP Toolkit is a collection of activities and assessments to support the developer through the ILAP. The sponsor may request to use any tool that is appropriate, and the partners will consider the request in the TDP Roadmap.
Examples of the tools available:
Adaptive inspections
Adaptive inspections can be used by developers to support the non-clinical, clinical, and manufacturing design and development pathway, to ensure protection of patients and reliability of results.
Continuous Benefit Risk Assessment integrating Real World Evidence
This tool provides guidance that ensures that the agreed approach delivers the right data, filling potential gaps in evidence within the right timeframe. Guidance provided throughout the procedure allows a proactive approach to data collection and post authorisation vigilance which is key in supporting approval of innovative medicines.
Patient engagement and assisted patient recruitment
A major effort is put into the patient engagement and ILAP embeds the patient voice and perspective right from the beginning. A pilot ILAP Patient Reference Group has been set up with members appointed by the MHRA, NICE, and SMC and provides valuable expertise and insights from the patient perspective throughout the process.
Innovative and Flexible Licensing Routes
These routes offer pragmatic approaches to evidence requirements and international options which can provide expedited timelines for review. ILAP partners can provide support and guidance for the choice of licensing routes such as rolling review, accelerated assessment or a conditional Marketing Authorisation as well as work-sharing pathways such as Access Consortium and Project Orbis. The TDP will recommend the most suitable routes to market, based on the product and patient population.
Novel Methodology and Innovative Clinical Trial Design
This tool is designed to establish a responsive setting that supports novel approaches during the pre-clinical and clinical phase. Novel trial design may increase the efficiency and effectiveness of clinical trials while maintaining high-quality data for regulatory decision making and reducing the burden for patients participating.
With a variety of available of services and additional tools in the pipeline, the ILAP offers a partnership-style early advice, with built-in flexibility and multiple entry points to streamline the development of new, cutting-edge medicines in the UK.
Are you planning to apply for approval in the UK? Talk to us!
Through our extensive experience of MHRA procedures, our dedicated team can help you make the right decisions to ensure the safest and quickest path to approval for your product.
