RareMoon’s Global Regulatory Expertise Accelerates Biotech Engagement in Europe and the UK

EMA’s Priority Medicines (PRIME) scheme and the UK’s Innovative Licensing and Access Pathway (ILAP) offer sponsors proactive regulatory dialogue, structured support with regulators, and potential acceleration of clinical development and market access. We guide clients in pursuit of these designations as part of a cohesive global strategy, layering EMA PRIME or ILAP alongside U.S. designations such as Fast Track or Breakthrough Therapy based on program maturity and data readiness.

PRIME provides enhanced early interaction with EMA to optimize development plans and speed the assessment of medicines that may offer a major therapeutic advantage. 

ILAP offers a unique UK-based framework for early support, including an Innovation Passport, Target Development Profile, and potential access to tools like rolling review. RareMoon delivers specialized regulatory insight and meticulous execution to both, enabling sponsors to align with European regulators from the earliest stages.

How RareMoon Partners PRIME and ILAP Designation efforts:

• Strategic evaluation of eligibility for PRIME or ILAP, including unmet need, therapeutic innovation, and clinical data readiness
• Preparation and submission of the PRIME application, including justifications for major public health interest and data demonstrating early promise
• Preparation of ILAP Innovation Passport applications in collaboration with MHRA, NICE, and other stakeholders
• Development of tailored briefing materials and sponsor coaching for EMA or ILAP meetings
• Support in establishing Target Development Profiles (TDPs) under ILAP, to align development plans with regulator expectations
• Cross-functional global strategy alignment, ensuring U.S., EU, and UK expedited programs support a cohesive development and access plan
• Post-designation regulatory engagement, including scientific advice, data package planning, and market access considerations

We understand each agency’s expectations and strategically position your product for proactive and enduring regulatory support from clinical development through approval and access.