Early Access to Medicines Scheme (EAMS) – UK

MHRA EAMS Application with Promising Innovative Medicine (PIM) designationStatutory90 days

Description & Eligibility

EAMS provides patients with life-threatening or seriously debilitating conditions access to promising medicines before full marketing authorization. The scheme includes a scientific opinion from MHRA on the benefit-risk balance based on early clinical data.

Eligibility Criteria

Patients with life-threatening or seriously debilitating conditions with significant unmet medical need, no alternative treatment available

Legal Reference / Source

Early Access to Medicines Scheme Regulations 2014

Countries Using This Pathway (1)

Early Access to Medicines Scheme (EAMS) – UK
Approval FormMHRA EAMS Application with Promising Innovative Medicine (PIM) designation
Timeline90 days
Legal StatusStatutory
Source Ref.Early Access to Medicines Scheme Regulations 2014
Countries1 countries
Compliance Check
Legal Review3/21/2026
Global ValidityVerified