Roche UK Confirms Submission of their Application for an Early Access to Medicines Scheme (EAMS)
05 May 2020
Yesterday, Roche took this next step with risdiplam which they had announced they planned to on 14th January 2020 when they stated:
“In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) governs the Early Access to Medicines Scheme (EAMS), ‘which aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need. Under the scheme, the Medicines and Healthcare products Regulatory Agency (MHRA) will give a scientific opinion on the benefit/risk balance of the medicine, based on the data available when the EAMS submission was made. (...) The scheme is voluntary and the opinion from MHRA does not replace the normal licensing procedures for medicines.’
In the absence of an EAMS and in line with Roche's position paper on Pre-Approval Access to lnvestigational Medicinal Products, individual compassionate use applications made to Roche UK by Healthcare Professionals on behalf of their patients will be considered in line with the global PAA/CU programme criteria as outlined in the global community letter.”
An EAMS application usually takes approximately 90 days to process, although in some circumstances it can be a little less.