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Priority Medicines initiative (PRIME) and Innovative Licensing and Access Pathway (ILAP)

We can 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 can help you plan, write, and submit these applications and ensure they offer maximum value to your overall regulatory plan.

Scientific Advice and Protocol Assistance (PRIME and ILAP) Resource

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Find out more about how to plan your scientific advice or protocol assistance. Also includes advice on PRIME and ILAP.

FAQs

What is PRIME?

PRIME is a scheme developed by the EMA to provide enhanced support and accelerated assessment for pharma and biotech companies hoping to get their product approved in the European Union (EU). The equivalent scheme in the USA is Breakthrough Therapy Designation.

What are the benefits of PRIME?

You will be given a dedicated Committee for Medicinal Products for Human Use / Committee on Advanced Therapies rapporteur; accelerated assessment timelines; and regulatory fee reductions and waivers for small and medium-sized enterprises.

What are the eligibility criteria for PRIME?

To be eligible for PRIME designation, your medicinal product should ideally be developed for conditions where there is an unmet medical need. This could be for conditions that have no alternative treatment options, or where the product being developed offers a substantial therapeutic benefit over existing treatments.

What is ILAP?

ILAP is the UK’s version of the PRIME scheme and the USA’s Breakthrough Therapy Designation. The MHRA designed this scheme following Brexit, to provide pharmaceutical and biotechnology companies a platform to accelerate their product’s time to approval, whilst offering enhanced support across all development stages.

What are the benefits of ILAP?

ILAP offers medicine developers an accelerated path to approval in the UK. The MHRA has partnered with leading organisations throughout the UK—including the UK’s health technology authority—to support your product development through to commercialisation.

years of regulatory expertise

clients supported

agency interactions

orphan applications

marketing applications