In its new role of an independent regulator, the UK’s MHRA regulatory agency is emerging as a flexible and welcoming supporter of new and innovative healthcare technologies and products. Since its launch, the Innovative Licensing and Access Pathway (ILAP) scheme has attracted continual attention of the industry. It has been one of the great successes, but it has also raised numerous queries.
In this session, we aim to guide your way through the application process and key noticing points of ILAP toward your marketing application and beyond, by answering questions such as:
- Can US person be an Applicant?
- Do Applicants get priority for other procedures/ Expedited development?
- Do Applicants need to show clinical data?
- At which stage do we recommend ILAP for Applicants?
- Is ILAP useful for EMA application?