Priority Medicines Initiative (PRIME) and Innovative Licensing & Access Pathway (ILAP)
We can advise you on how to approach PRIME and ILAP for maximum return on your resources and with the greatest likelihood of getting accepted onto a scheme.
Streamline submissions
We plan, write, and submit application - adding maximum value to your overall regulatory plan.
Gain acceptance
We can help you increase your chance of getting accepted onto a scheme.
Maximise return
We can advise you on how to approach PRIME and ILAP for the greatest return on your resources.
The Priority Medicines (PRIME) scheme and the Innovative Licensing and Access Pathway (ILAP) are regulatory pathways offering enhanced support to medicine developers.
What is the PRIME Scheme?
The European Medicines Agency’s PRIME scheme is usually reserved for products with early clinical proof-of-concept data. The bar for acceptance onto PRIME is high – around 80% of applications are rejected. The endorsement that acceptance onto the PRIME scheme brings is similar to the breakthrough therapy designation in the USA.
What is ILAP?
The Medicines and Healthcare Products Regulatory Authority’s (MHRA’s) ILAP pathway is designed for products earlier in development and has a higher rate of acceptance. During ILAP, the MHRA will provide several ‘tools’ to help sponsors, including supporting the development of the target development plan.
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Find out more about how to plan your scientific advice or protocol assistance. Also includes advice on PRIME and ILAP.
How does the EMA’s PRIME Scheme benefit medicine developers?
Early Engagement with EMA Experts:
Developers are assigned a scientific coordinator and have access to multidisciplinary expert groups to guide their development plans.
Early rapporteur appointment:
Medicine developers are offered a consolidated development overview with a kick-off meeting, guiding the overall development and regulatory strategy.
EMA dedicated contact point:
The EMA PRIME Scientific Coordinator supports the developer throughout the scheme.
Streamlined Regulatory Support:
Iterative and expedited scientific advice is offered, allowing developers to address key issues, with opportunities to involve health technology assessment (HTA) bodies, and the Food and Drug Administration (FDA).
Accelerated Assessment:
Medicines under PRIME are expected to be eligible for accelerated assessment during marketing authorisation applications, ensuring faster approval processes.
Tailored Support for SMEs and Academia:
Small businesses and academic researchers receive additional support, such as fee exemptions for scientific advice, advice on generating proof of concept data and regulatory advice to navigate regulatory milestones. The Medicines and Healthcare Products Regulatory Authority’s (MHRA’s) ILAP pathway is designed for products earlier in development and has a higher rate of acceptance. During ILAP, the MHRA will provide several ‘tools’ to help sponsors, including supporting the development of the target development plan.
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Our monthly newsletter gives you the latest European and UK regulatory intelligence. We bring you new and interesting approvals; fast-to-market applications, orphan designations; paediatric applications and therapy area-specific news.
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NOTE: The first step for innovation passport holders is the TDP, which is a bespoke roadmap for applicants. It is designed as a ‘living document’, updated as the programme develops, and new knowledge is gained.
How Somerville Development Partners can help you
Somerville Development Partners can advise you on how to approach PRIME and ILAP for the greatest return on your resources and with the greatest likelihood of getting accepted onto a scheme.
We help companies with enhanced regulatory engagement interactions, such as the European Medicines Agency’s (EMA’s) PRIME and the Medicines and Healthcare Products Regulatory Agency’s (MHRA’s) ILAP.
We will plan, write, and submit these applications and ensure they offer maximum value to your overall regulatory plan. An outline of the structure and strategy for the PIP, plus recommended submission timing and potential challenges during the evaluation.
Subscribe to our Monthly Regulatory Intelligence Scan
Our monthly newsletter gives you the latest European and UK regulatory intelligence. We bring you new and interesting approvals; fast-to-market applications, orphan designations; paediatric applications and therapy area-specific news.
You can unsubscribe at any time from the link in the newsletter footer. Read our Privacy Policy here.