Four years after the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) introduced the Innovative Licensing and Access Pathway or ILAP, the agency is rolling out a revamped version of the program. Let’s call it ILAP 2.0. While the program’s primary aims (expediting approvals and getting innovative therapies into patients’ hands quicker) remain unchanged, several notable modifications were made at the behest of industry.
For anyone considering ILAP as an approval pathway, Certara’s global market access experts prepared a primer on the relaunch that includes accomplishments to date, a summary of process changes, and critical distinctions about the criteria products must meet for entry.
The white paper goes in depth on several topics of great interest:
- The step-by-step ILAP process and key milestones
- Products in scope and not in scope
- Selection criteria used to determine suitability for an Innovation Passport
- Broader implications for drug developers
Complete the form to download the free white paper and learn everything you need to know about ILAP 2.0.
作者：
Elzbieta Soltysiak
Senior Consulting Manager, Evidence and Access
Elzbieta has 15+ years’ experience in healthcare and medical research. She earned a PhD and MSc and continues to develop a diverse skill set with multiple areas of expertise. Her career includes 10+ years in Health Technology Assessment (HTA), evidence-based medicine (EBM), and market access and reimbursement, as well as 6 years in researching materials for medical applications.
Jelena Sostar, MSc
Senior Consulting Manager, Evidence and Access
Jelena brings a strong scientific background and diverse skill set to Certara Evidence and Access. She began as a research analyst, and currently manages a variety of projects including secondary research and primary research with KOLs and payers. Jelena supports the development of access strategies and tools such as burden of illness insights, global value dossiers and payer value propositions spanning all stages of clinical development.
