Our Associate Director, Dr Graeme Deuchar, will be presenting an “Overview and Real World Experience of MHRA’s PIM Designation / Early Access to Medicines Scheme” at the next TOPRA in Scotland meeting. The meeting will be held on 27 September 2018 from 14.00 until 17.00, hosted by IQVIA Livingston.
In April 2014, the Early Access to Medicines Scheme (EAMS) was launched in the UK. EAMS is a mechanism enabling early patient access in the UK to important medicines targeted for the treatment, diagnosis or prevention of seriously debilitating or life threatening conditions, prior to submitting a full marketing authorisation.
The PIM designation, which represents step I of the EAMS, provides sponsors with an opportunity to interact with regulators and receive validation of a product earlier in clinical development. Importantly, a PIM designation indicates that the UK Regulatory Agency, the MHRA, considers the product to be a promising candidate for entry into stage II of EAMS, where the sponsor has the opportunity to receive advice related to the clinical development programme from the MHRA and NICE / SMC, and the possibility to make the product available to patients in UK ahead of a full marketing authorisation.