The MHRA is seeking views on the proposed changes to the UK Human Medicines Regulations 2012 ( Human Medicine Regulations 2012(external link opens in a new window / tab) ). The objective of the proposal is to ensure that the Early Access to Medicines Scheme (EAMS) remains an attractive option for patients, healthcare professionals and companies, so that cutting-edge therapies are available for patients where there is an unmet clinical need.
The aim is to make the legal basis for EAMS supply clear and minimise the burden on those supplying EAMS medicines and for those companies wishing to collect real-world data during the scheme. This will be delivered whilst continuing to ensure the safety of EAMS products through pharmacovigilance (safety monitoring), maximising patient access and benefit.
Link to Consultation Documents:
Early Access to Medicines Scheme (EAMS) Consultation - GOV.UK (www.gov.uk), and the response form can be accessed here.