MHRA grants first scientific opinion
Dr Ian Hudson, Chief Executive of Medicines and Healthcare Products Regulatory Agency, comments on the first scientific opinion granted in the UK.
Chief Executive of the Medicines and Healthcare Products Regulatory Agency, Dr Ian Hudson said:
We are delighted to issue the first positive Early Access to Medicines Scheme (EAMS) scientific opinion. Following assessment of data on quality, safety and efficacy, a positive scientific opinion has been awarded for a medicine used to treat advanced melanoma (a form of skin cancer). The scientific opinion describes the risks and benefits of the medicine and the context for its use, supporting the prescriber and patient to make a decision on whether to use the medicine before its licence is approved.
This UK only scheme supports earlier access of unlicensed medicine in patients with seriously debilitating or life threatening conditions where there is an unmet medical need.
More details about the EAMS positive scientic opinion is in the Department of Health’s press release and our publication .
For further information on EAMS see our detailed guide.