The Medicines and Healthcare Products Regulatory Agency (MHRA) published guidance on "Apply for the early access to medicines scheme (EAMS)" on 16 August, 2024 that is designed to provide patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a full marketing authorization. This scheme is valuable when there is a clear unmet medical need, and the medicine in question shows promising results during early clinical trials.
For a medicine to be considered under EAMS, it must meet specific criteria:
The condition being treated is life-threatening or seriously debilitating.
There is a clear unmet medical need, meaning no satisfactory treatment is available, or the new treatment offers significant advantages over existing options.
Based on early clinical data, The medicinal product will likely offer major benefits to patients.
The company has demonstrated the intention to submit a marketing authorization application within a reasonable timeframe.
The application for EAMS is a two-stage process:
Step 1: Promising Innovative Medicine (PIM) Designation: The first stage involves obtaining a PIM designation, which indicates that the MHRA considers the medicine a promising candidate for EAMS. The PIM designation is based on preliminary data showing the potential for significant improvement in the treatment of a life-threatening condition.
Step 2: EAMS Scientific Opinion: After obtaining the PIM designation, the company can apply for a scientific opinion. This involves a more detailed assessment of the medicine’s quality, safety, and efficacy based on available data. The scientific opinion, if positive, allows the medicine to be made available to patients under EAMS.
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 decide 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.
A public assessment report (PAR) and the EAMS treatment protocol will be published on GOV.UK following a positive scientific opinion and the PAR will include:
how the product is used and how it works
summary of the key clinical studies
the risks and benefits of the product
the reason for the positive EAMS scientific opinion
any uncertainties
information about ongoing clinical studies
measures in place to monitor and manage risk
For more detailed information on the Early Access to Medicines Scheme (EAMS) and the application process, please refer to the official MHRA guidance.
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