Snapshot

The Early Access to Medicines Scheme (EAMS) pathway has been developed by the of United Kingdom.

This pathway can be used where Medicines that do not yet have a marketing authorisation but meet a medical need that is currently not being met. Medicinal products expected to be included in the scheme are those that are intended to treat, diagnose or prevent seriously debilitating or life threatening conditions..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

The scientific opinion will be provided after a 2-step evaluation process: the promising innovative medicine (PIM) designation, and the early access to medicines scientific opinion. The PIM designation will give an indication that a product may be eligible for the EAMS based on early clinical data. The PIM designation will be issued after an MHRA scientific meeting and could be given several years before the product is licensed. The scientific opinion describes the risks and benefits of the medicine based on data gathered from the patients who will benefit from the medicine. The opinion supports the prescriber and patient to make a decision on whether to use the medicine before its licence is approved. If you want to apply for an EAMS scientific opinion from MHRA you must have a PIM designation. You should also attend a pre-submission meeting with MHRA to ensure that your product is suitable for an EAMS scientific opinion application and to discuss the format of the data you need to submit to support the opinion. All Applicants will receive an initial benefit/risk opinion by Day 45 of the procedure. If a preliminary positive opinion is given, the procedure follows the Day 75 timetable, with a 15-day clock stop period. If the preliminary benefit/risk opinion is negative, the procedure follows the Day 90 timetable, with a 30-day clock stop (this may be extended to 60 days in exceptional circumstances). The clock stop period allows time for an Applicant to respond to outstanding major (30 days) or minor (15 days) issues. Response to the outstanding issues should be provided within the stated time. The EAMS dossier should be submitted in electronic format by the date specified and agreed after the pre-submission meeting. Late or invalid dossiers will not be able to enter the scheme on the preferred date. For help and advice regarding the submission process, please contact the EAMS co-ordinator (eams@mhra.gsi.gov.uk).