The early access to medicines scheme (EAMS) was introduced by the MHRA with the objective of providing patients with life-threatening or seriously debilitating conditions, access to medicines that have not yet received a Marketing Authorisation and addresses an unmet medical need. Since the scheme was launched in 2014 over 1,200 people from across the UK, with conditions ranging from cancer to Duchenne Muscular Dystrophy, have benefited from early access to new treatments.
The scheme does not replace the normal licensing routes, however if criteria are met, it provides a scientific opinion to support prescribers and patients to decide on whether to use the medicine up to 18 months before the Marketing Authorisation is granted.
EAMS applications submitted to the MHRA undergo a 2-step evaluation process:
1) The promising innovative medicine (PIM) designation
The PIM designation indicates whether a product may be eligible for the EAMS based on early clinical data. The PIM designation is issued following a MHRA scientific meeting.
2) The EAMS scientific opinion
To proceed to this second step, you must have a PIM designation and attend a MHRA pre-submission meeting. The MHRA begin by determining the risk/benefit ratio of the medicine. This is then followed by a scientific opinion which is based on the data available at the time of the submission.
Once a positive opinion is issued it remains valid for 1 year which can be renewed. Additionally, the MHRA will publish a public assessment report (PAR) together with the EAMS treatment protocol.
The MHRA have published guidance on how companies can apply for EAMS and have useful documentation outlining the process, including a schematic overview, dates for submission and related fees.
If you would like to discuss how Fusion Pharma can support you with your EAMS application, please email us at firstname.lastname@example.org or phone us on +44 (0) 203 1379 799.